30 jobs in Par Health
Analyst, Quality Control
Pudupakkam
Par Health
Posted 12 days ago
Job Viewed
Job Description
**Job Description Summary**
Experienced Analytical/Quality Control Analyst with 3-5 years of hands-on experience in an FDA-regulated pharmaceutical environment. Proficient in performing analytical testing of drug products and raw materials using techniques such as HPLC, GC, UV, and dissolution. Skilled in handling stability samples, method execution, data integrity compliance, and troubleshooting laboratory instruments. Strong understanding of cGMP, GLP, and FDA regulatory requirements, with a proven ability to ensure accurate documentation and compliance during audits and inspections.
**Job Description**
+ Perform routine and stability sample analysis as per approved specifications and test methods
+ Operate and maintain analytical instruments (HPLC, GC, UV, Dissolution Apparatus, etc.)
+ Review and document analytical data in compliance with cGMP and data integrity principles
+ Investigate OOS/OOT results and support deviation and CAPA activities
+ Ensure compliance with FDA, cGMP, and GLP requirements
+ Prepare and review analytical reports, protocols, and SOPs
+ Participate in method transfer, verification, and validation activities
+ Support regulatory and internal audits
+ Strong knowledge of FDA regulations, cGMP, and data integrity
+ Analytical troubleshooting and problem-solving skills
+ Documentation and compliance expertise
+ Team collaboration and communication
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Experienced Analytical/Quality Control Analyst with 3-5 years of hands-on experience in an FDA-regulated pharmaceutical environment. Proficient in performing analytical testing of drug products and raw materials using techniques such as HPLC, GC, UV, and dissolution. Skilled in handling stability samples, method execution, data integrity compliance, and troubleshooting laboratory instruments. Strong understanding of cGMP, GLP, and FDA regulatory requirements, with a proven ability to ensure accurate documentation and compliance during audits and inspections.
**Job Description**
+ Perform routine and stability sample analysis as per approved specifications and test methods
+ Operate and maintain analytical instruments (HPLC, GC, UV, Dissolution Apparatus, etc.)
+ Review and document analytical data in compliance with cGMP and data integrity principles
+ Investigate OOS/OOT results and support deviation and CAPA activities
+ Ensure compliance with FDA, cGMP, and GLP requirements
+ Prepare and review analytical reports, protocols, and SOPs
+ Participate in method transfer, verification, and validation activities
+ Support regulatory and internal audits
+ Strong knowledge of FDA regulations, cGMP, and data integrity
+ Analytical troubleshooting and problem-solving skills
+ Documentation and compliance expertise
+ Team collaboration and communication
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this job a match or a miss?
Apply Now
0
Analyst, Global Stability
Pudupakkam
Par Health
Posted 12 days ago
Job Viewed
Job Description
**Job Description Summary**
QC Analyst with 3-6 years of experience in pharmaceutical quality control, skilled in routine in‑process samples, and finished products. Experienced in instrumental analysis (HPLC, GC, UV, Dissolution), method execution as per approved SOPs, OOS/OOT investigations, and data integrity compliance. Well‑versed in GMP, documentation practices, and regulatory guidelines, with strong analytical and problem‑solving skills.
**Job Description**
+ Perform routine QC testing of raw materials, intermediates, and finished products using approved analytical methods.
+ Conduct instrumental analysis including HPLC, GC, UV-Vis, Dissolution, and wet chemistry techniques.
+ Execute stability studies, compile data, trend results, and prepare stability reports.
+ Review and ensure accuracy, completeness, and compliance of analytical data and documentation.
+ Handle OOS, OOT, deviations, and laboratory incidents, including root cause analysis and implementation of CAPAs.
+ Ensure compliance with cGMP, data integrity (ALCOA+), SOPs, and regulatory guidelines.
+ Support method transfers, method verifications, and analytical method validations as required.
+ Maintain laboratory equipment, perform calibrations, and ensure proper documentation of laboratory activities.
+ Participate in internal audits, regulatory inspections, and continuous improvement initiatives.
+ Coordinate with cross‑functional teams such as QA, Manufacturing, and Regulatory Affairs as needed.
+ Proficiency in laboratory documentation and electronic systems (LIMS preferred).
+ Good problem‑solving, analytical, and communication skills.
+ Ability to work independently as well as collaboratively in a regulated environment.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
QC Analyst with 3-6 years of experience in pharmaceutical quality control, skilled in routine in‑process samples, and finished products. Experienced in instrumental analysis (HPLC, GC, UV, Dissolution), method execution as per approved SOPs, OOS/OOT investigations, and data integrity compliance. Well‑versed in GMP, documentation practices, and regulatory guidelines, with strong analytical and problem‑solving skills.
**Job Description**
+ Perform routine QC testing of raw materials, intermediates, and finished products using approved analytical methods.
+ Conduct instrumental analysis including HPLC, GC, UV-Vis, Dissolution, and wet chemistry techniques.
+ Execute stability studies, compile data, trend results, and prepare stability reports.
+ Review and ensure accuracy, completeness, and compliance of analytical data and documentation.
+ Handle OOS, OOT, deviations, and laboratory incidents, including root cause analysis and implementation of CAPAs.
+ Ensure compliance with cGMP, data integrity (ALCOA+), SOPs, and regulatory guidelines.
+ Support method transfers, method verifications, and analytical method validations as required.
+ Maintain laboratory equipment, perform calibrations, and ensure proper documentation of laboratory activities.
+ Participate in internal audits, regulatory inspections, and continuous improvement initiatives.
+ Coordinate with cross‑functional teams such as QA, Manufacturing, and Regulatory Affairs as needed.
+ Proficiency in laboratory documentation and electronic systems (LIMS preferred).
+ Good problem‑solving, analytical, and communication skills.
+ Ability to work independently as well as collaboratively in a regulated environment.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this job a match or a miss?
Apply Now
1
Deputy Manager, Technical Services (Chennai/Indore)
Pudupakkam
Par Health
Posted 12 days ago
Job Viewed
Job Description
**Job Description Summary**
To manage and execute packaging development, validation, and shop floor operations in compliance with regulatory requirements, ensuring robustness, efficiency, and compliance of packaging systems across regulated markets.
**Job Description**
Key Responsibilities:
1. Artwork Evaluation & Approval:
- Review and evaluate packaging artworks for compliance with regulatory and marketing requirements
- Coordinate with QA, Regulatory Affairs, and vendors for artwork approval
- Ensure correct implementation of printed packaging materials
2. Packaging Development & Change Management:
- Design and develop primary, secondary, and tertiary packaging configurations
- Manage packaging change parts design, modification, and implementation
- Execute feasibility studies and provide technical inputs for new product introduction
- Ensure compatibility of packaging with product and machinery
3. Material Approval System (MAS):
- Initiate and manage material approval processes
- Evaluate vendor samples and ensure compliance to specifications
- Support vendor qualification and packaging material standardization
4. Packaging Specifications & Documentation:
- Develop and review packaging specifications
- Prepare Master Packaging Records (MPR), SOPs, protocols, and reports
- Ensure documentation aligns with cGMP and regulatory requirements
5. Shipping Studies & Stability Support:
- Design and execute shipping validation studies
- Support packaging design for transportation robustness
6. Packaging Validation & Qualification:
- Execute packaging validation (PV)
- Support equipment qualification (IQ/OQ/PQ)
- Ensure compliance with validation requirements
7. MVTR Evaluation:
- Conduct and interpret MVTR studies
- Evaluate barrier properties of packaging materials
8. Shop Floor Monitoring & Support:
- Monitor packaging operations
- Provide troubleshooting support
9. Equipment Handling:
- Experience in bottle, blister, pouch,sachet and secondary packing machines
- Support machine trials and optimization
10. Regulatory Compliance & cGMP:
- Ensure compliance with USFDA/EU/WHO regulations
- Support audits and maintain inspection readiness
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
To manage and execute packaging development, validation, and shop floor operations in compliance with regulatory requirements, ensuring robustness, efficiency, and compliance of packaging systems across regulated markets.
**Job Description**
Key Responsibilities:
1. Artwork Evaluation & Approval:
- Review and evaluate packaging artworks for compliance with regulatory and marketing requirements
- Coordinate with QA, Regulatory Affairs, and vendors for artwork approval
- Ensure correct implementation of printed packaging materials
2. Packaging Development & Change Management:
- Design and develop primary, secondary, and tertiary packaging configurations
- Manage packaging change parts design, modification, and implementation
- Execute feasibility studies and provide technical inputs for new product introduction
- Ensure compatibility of packaging with product and machinery
3. Material Approval System (MAS):
- Initiate and manage material approval processes
- Evaluate vendor samples and ensure compliance to specifications
- Support vendor qualification and packaging material standardization
4. Packaging Specifications & Documentation:
- Develop and review packaging specifications
- Prepare Master Packaging Records (MPR), SOPs, protocols, and reports
- Ensure documentation aligns with cGMP and regulatory requirements
5. Shipping Studies & Stability Support:
- Design and execute shipping validation studies
- Support packaging design for transportation robustness
6. Packaging Validation & Qualification:
- Execute packaging validation (PV)
- Support equipment qualification (IQ/OQ/PQ)
- Ensure compliance with validation requirements
7. MVTR Evaluation:
- Conduct and interpret MVTR studies
- Evaluate barrier properties of packaging materials
8. Shop Floor Monitoring & Support:
- Monitor packaging operations
- Provide troubleshooting support
9. Equipment Handling:
- Experience in bottle, blister, pouch,sachet and secondary packing machines
- Support machine trials and optimization
10. Regulatory Compliance & cGMP:
- Ensure compliance with USFDA/EU/WHO regulations
- Support audits and maintain inspection readiness
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this job a match or a miss?
Apply Now
2
Sr Mgr, Quality Assurance
Pudupakkam
Par Health
Posted 12 days ago
Job Viewed
Job Description
**Job Description Summary**
This position is responsible for ensuring that the final product observes the company's quality standards and for the development and implementation of inspection activities, the detection and resolution of problems, and the delivery of quality product.
**Job Description**
+ Review & approval of Process, Packaging validation, Submission and Engineering batch protocol/ report
+ Master Batch record review (Validation, scale up, Exhibit, Engineering, Commercial)
+ Executed Batch records review (Validation, scale up, Exhibit, Engineering, Commercial)
+ Handling of New Product introduction activity
+ Review & approval of protocols & reports as a part of Investigation
+ Hold time study protocol/ report review & approval
+ Review & approval of cleaning validation protocols, verification protocols and reports.
+ SOP preparation and review
+ Performing & Handling of self-inspection activity.
+ Review & approval of risk assessments & impact assessment
+ Root cause identification and Incident investigation activities
+ Commercial dispatch activity as per site monthly schedule
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
This position is responsible for ensuring that the final product observes the company's quality standards and for the development and implementation of inspection activities, the detection and resolution of problems, and the delivery of quality product.
**Job Description**
+ Review & approval of Process, Packaging validation, Submission and Engineering batch protocol/ report
+ Master Batch record review (Validation, scale up, Exhibit, Engineering, Commercial)
+ Executed Batch records review (Validation, scale up, Exhibit, Engineering, Commercial)
+ Handling of New Product introduction activity
+ Review & approval of protocols & reports as a part of Investigation
+ Hold time study protocol/ report review & approval
+ Review & approval of cleaning validation protocols, verification protocols and reports.
+ SOP preparation and review
+ Performing & Handling of self-inspection activity.
+ Review & approval of risk assessments & impact assessment
+ Root cause identification and Incident investigation activities
+ Commercial dispatch activity as per site monthly schedule
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this job a match or a miss?
Apply Now
3
Analyst, Microbiology (QC)
Pudupakkam
Par Health
Posted 12 days ago
Job Viewed
Job Description
**Job Description Summary**
To Perform the analysis of Raw materials, Finished, Stability and Swab samples or any other test samples as per approved specifications and test methods.
To Perform the sampling and analysis of water samples as per approved schedule and test methods.
To Perform the Environmental monitoring in Manufacturing and Microbiology Area.
To Perform for releasing of Water, Raw materials, Finished, Stability and Swab samples or any other test samples.
To Perform releasing of Environmental monitoring samples.
To Perform monitoring of temperature for instruments.
To Perform periodic calibration of equipments and instruments.
To Perform handling of media and cultures.
To Perform microbial method validation.
To maintain respective working area, documents, and records in auditable manner.
To follow the safety, cGLP and cGDP in work area.
To attend and complete the training activities whenever assigned.
To ensure lab compliance during daily routine activities.
Initiating events/change requests based on daily lab activities.
Maintain a high standard of 5S practices at our workplace, through teamwork and self-discipline.
**Job Description**
To perform the analysis of In-process sample, Hold Time, Finished product, Stability samples, Instrument Calibration and any other analytical testing based on routine requirement.
- Reporting and documenting the analytical data as per good laboratory practices and Good documentation practices.
- To perform the analytical method transfer, method verification/validation as per requirement.
- To maintain respective working area, documents, and records in auditable manner.
- To follow the safety, cGLP and cGDP in work area.
- To attend and complete the training activities whenever assigned.
- To ensure lab compliance during daily routine activities.
- Initiating events/change requests based on daily lab activities.
- Maintain a high standard of 5S practices at our workplace, through teamwork and self-discipline.
- Follow safety instructions at all times at the workplace. Should follow safety guidelines in the interest of self, environment and property and community at large.
To perform the analysis of In-process sample, Hold Time, Finished product, Stability samples, Instrument Calibration and any other analytical testing based on routine requirement.
- Reporting and documenting the analytical data as per good laboratory practices and Good documentation practices.
- To perform the analytical method transfer, method verification/validation as per requirement.
- To maintain respective working area, documents, and records in auditable manner.
- To follow the safety, cGLP and cGDP in work area.
- To attend and complete the training activities whenever assigned.
- To ensure lab compliance during daily routine activities.
- Initiating events/change requests based on daily lab activities.
- Maintain a high standard of 5S practices at our workplace, through teamwork and self-discipline.
- Follow safety instructions at all times at the workplace. Should follow safety guidelines in the interest of self, environment and property and community at large.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
To Perform the analysis of Raw materials, Finished, Stability and Swab samples or any other test samples as per approved specifications and test methods.
To Perform the sampling and analysis of water samples as per approved schedule and test methods.
To Perform the Environmental monitoring in Manufacturing and Microbiology Area.
To Perform for releasing of Water, Raw materials, Finished, Stability and Swab samples or any other test samples.
To Perform releasing of Environmental monitoring samples.
To Perform monitoring of temperature for instruments.
To Perform periodic calibration of equipments and instruments.
To Perform handling of media and cultures.
To Perform microbial method validation.
To maintain respective working area, documents, and records in auditable manner.
To follow the safety, cGLP and cGDP in work area.
To attend and complete the training activities whenever assigned.
To ensure lab compliance during daily routine activities.
Initiating events/change requests based on daily lab activities.
Maintain a high standard of 5S practices at our workplace, through teamwork and self-discipline.
**Job Description**
To perform the analysis of In-process sample, Hold Time, Finished product, Stability samples, Instrument Calibration and any other analytical testing based on routine requirement.
- Reporting and documenting the analytical data as per good laboratory practices and Good documentation practices.
- To perform the analytical method transfer, method verification/validation as per requirement.
- To maintain respective working area, documents, and records in auditable manner.
- To follow the safety, cGLP and cGDP in work area.
- To attend and complete the training activities whenever assigned.
- To ensure lab compliance during daily routine activities.
- Initiating events/change requests based on daily lab activities.
- Maintain a high standard of 5S practices at our workplace, through teamwork and self-discipline.
- Follow safety instructions at all times at the workplace. Should follow safety guidelines in the interest of self, environment and property and community at large.
To perform the analysis of In-process sample, Hold Time, Finished product, Stability samples, Instrument Calibration and any other analytical testing based on routine requirement.
- Reporting and documenting the analytical data as per good laboratory practices and Good documentation practices.
- To perform the analytical method transfer, method verification/validation as per requirement.
- To maintain respective working area, documents, and records in auditable manner.
- To follow the safety, cGLP and cGDP in work area.
- To attend and complete the training activities whenever assigned.
- To ensure lab compliance during daily routine activities.
- Initiating events/change requests based on daily lab activities.
- Maintain a high standard of 5S practices at our workplace, through teamwork and self-discipline.
- Follow safety instructions at all times at the workplace. Should follow safety guidelines in the interest of self, environment and property and community at large.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this job a match or a miss?
Apply Now
4
Senior Analyst, Quality Control
Pudupakkam
Par Health
Posted 12 days ago
Job Viewed
Job Description
**Job Description Summary**
Senior Analyst responsible for executing and overseeing complex analytical tasks while ensuring accuracy, quality, and compliance with organizational or regulatory standards. The role involves interpreting data, troubleshooting issues, and providing insights to support decision-making and continuous improvement.
**Job Description**
+ Perform and review routine and non-routine analyses with high accuracy
+ Ensure adherence to standard operating procedures (SOPs), regulatory, and quality requirements
+ Evaluate and interpret analytical data, identifying trends and discrepancies
+ Investigate out-of-specification (OOS) or out-of-trend (OOT) results
+ Provide technical guidance and mentorship to junior analysts
+ Support method validation, transfer, and troubleshooting activities
+ Maintain proper documentation and ensure data integrity practices
+ Coordinate with cross-functional teams to meet project timelines and objectives
+ Strong analytical and problem-solving abilities
+ Attention to detail and data accuracy
+ Knowledge of relevant instruments, techniques, and regulatory guidelines
+ Effective communication and reporting skills
+ Leadership and team support capabilities
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Senior Analyst responsible for executing and overseeing complex analytical tasks while ensuring accuracy, quality, and compliance with organizational or regulatory standards. The role involves interpreting data, troubleshooting issues, and providing insights to support decision-making and continuous improvement.
**Job Description**
+ Perform and review routine and non-routine analyses with high accuracy
+ Ensure adherence to standard operating procedures (SOPs), regulatory, and quality requirements
+ Evaluate and interpret analytical data, identifying trends and discrepancies
+ Investigate out-of-specification (OOS) or out-of-trend (OOT) results
+ Provide technical guidance and mentorship to junior analysts
+ Support method validation, transfer, and troubleshooting activities
+ Maintain proper documentation and ensure data integrity practices
+ Coordinate with cross-functional teams to meet project timelines and objectives
+ Strong analytical and problem-solving abilities
+ Attention to detail and data accuracy
+ Knowledge of relevant instruments, techniques, and regulatory guidelines
+ Effective communication and reporting skills
+ Leadership and team support capabilities
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this job a match or a miss?
Apply Now
5
Quality Assurance Senior Associate
Pudupakkam
Par Health
Posted 12 days ago
Job Viewed
Job Description
**Job Description Summary**
Responsible for planning and Execution of Shopfloor IPQA activities.
Responsible for Authorizing the Line Clearance during the product change over in warehouse and production (manufacturing and packing ).
Responsible for Conducting quality examination in regular intervals by performing in-process checks during the production process.
**Job Description**
Responsible for planning and Execution of Shopfloor IPQA activities.
Responsible for Authorizing the Line Clearance during the product change over in warehouse and production (manufacturing and packing ).
Responsible for Conducting quality examination in regular intervals by performing in-process checks during the production process.
esponsible to perform Sampling of intermediates finished drug products, Reserve samples & stability samples from manufacturing and Packing stages and submission to Quality Control unit for testing.
Responsible for Involvement in hold time study program by performing the sampling and retaining the required sample in controlled storage. Submission of sample to quality control lab on regular intervals as per sampling plan.
Responsible for ensuring the compliance and performing calibration of IPQC-Instrument.
Responsible for to follow the procedures pertaining to the environmental management system and review of EMS alarm history, e-sign with appropriate comments. Report any observation/non-conformance related to the environment management system.
Responsible for Acknowledgement of Maintenance request and performing the impact assessment before closure.
Responsible for performing visual inspection, destruction of reserve sample and Maintenance of reserve sample room.
Responsible for performing product inspection for physical defects as defects as defined frequency in batch record and ensuring the compliance.
Responsible for review batch records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.
Responsible for release the bulk, Posting sample quantity and other QA associated transaction in SAP.
Responsible for approving or rejecting all procedures impacting on the identity, strength, quality, and purity of the drug product.
Responsible for follow the written procedure applicable to job description.
Responsible for to adherence of cGMP in all activities performed and responsible for compliance.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Responsible for planning and Execution of Shopfloor IPQA activities.
Responsible for Authorizing the Line Clearance during the product change over in warehouse and production (manufacturing and packing ).
Responsible for Conducting quality examination in regular intervals by performing in-process checks during the production process.
**Job Description**
Responsible for planning and Execution of Shopfloor IPQA activities.
Responsible for Authorizing the Line Clearance during the product change over in warehouse and production (manufacturing and packing ).
Responsible for Conducting quality examination in regular intervals by performing in-process checks during the production process.
esponsible to perform Sampling of intermediates finished drug products, Reserve samples & stability samples from manufacturing and Packing stages and submission to Quality Control unit for testing.
Responsible for Involvement in hold time study program by performing the sampling and retaining the required sample in controlled storage. Submission of sample to quality control lab on regular intervals as per sampling plan.
Responsible for ensuring the compliance and performing calibration of IPQC-Instrument.
Responsible for to follow the procedures pertaining to the environmental management system and review of EMS alarm history, e-sign with appropriate comments. Report any observation/non-conformance related to the environment management system.
Responsible for Acknowledgement of Maintenance request and performing the impact assessment before closure.
Responsible for performing visual inspection, destruction of reserve sample and Maintenance of reserve sample room.
Responsible for performing product inspection for physical defects as defects as defined frequency in batch record and ensuring the compliance.
Responsible for review batch records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.
Responsible for release the bulk, Posting sample quantity and other QA associated transaction in SAP.
Responsible for approving or rejecting all procedures impacting on the identity, strength, quality, and purity of the drug product.
Responsible for follow the written procedure applicable to job description.
Responsible for to adherence of cGMP in all activities performed and responsible for compliance.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this job a match or a miss?
Apply Now
6
Quality Assurance Deputy Manager
Pudupakkam
Par Health
Posted 12 days ago
Job Viewed
Job Description
**Job Description Summary**
The Incoming person shall handle QMS with a special focus to Change Controls, Complaints, APQRS and Self Inspection
**Job Description**
Preparation, Review and approval of Annual Product Review.
Logging of complaints & Intake, follow up and investigation of market complaints.
Change control management of entire site. Responsible for review and evaluation of change control.
Conduct reviewer qualification based on the request and to maintain qualified reviewer list.
Conducting the self-inspection, walk-through audit as per schedule/plan, reporting and follow up for relevant actions.
Preparation, review and approval of standard Operating Procedures.
Gap assessment of procedures.
Preparation, review and approval of Risk Assessment.
Responsible for Initiation, review, implementation and closure of Deviations and CAPA.
Support of internal / regulatory audits conducted at site.
Preparations, review and approval of protocols and reports.
Support for the preparation of Quality monthly reports.
Responsible to keep the workplace neat and clean. Maintain 5S and support for its improvement.
Responsible to perform any other work assigned by HOD.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
The Incoming person shall handle QMS with a special focus to Change Controls, Complaints, APQRS and Self Inspection
**Job Description**
Preparation, Review and approval of Annual Product Review.
Logging of complaints & Intake, follow up and investigation of market complaints.
Change control management of entire site. Responsible for review and evaluation of change control.
Conduct reviewer qualification based on the request and to maintain qualified reviewer list.
Conducting the self-inspection, walk-through audit as per schedule/plan, reporting and follow up for relevant actions.
Preparation, review and approval of standard Operating Procedures.
Gap assessment of procedures.
Preparation, review and approval of Risk Assessment.
Responsible for Initiation, review, implementation and closure of Deviations and CAPA.
Support of internal / regulatory audits conducted at site.
Preparations, review and approval of protocols and reports.
Support for the preparation of Quality monthly reports.
Responsible to keep the workplace neat and clean. Maintain 5S and support for its improvement.
Responsible to perform any other work assigned by HOD.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this job a match or a miss?
Apply Now
7
Sr Analyst, Quality Control
Pudupakkam
Par Health
Posted 12 days ago
Job Viewed
Job Description
**Job Description Summary**
To perform the analysis of In-process sample, Hold Time , Finished product and stability samples, analytical testing based on routine requirement.
- Reporting and documenting the analytical data as per good laboratory practices and Good documentation practices.
- To follow the safety, cGLP and cGDP in work area.
- To attend and complete the training activities whenever assigned.
- To ensure lab compliance during daily routine activities.
- Initiating events/change requests based on daily lab activities.
- Maintain a high standard of 5S practices at our workplace, through teamwork and self-discipline.
- Follow safety instructions at all times at the workplace. Should follow safety guidelines in the interest of self, environment and property and community at large.
**Job Description**
To perform the analysis of In-process sample, Hold Time , Finished product and stability samples, analytical testing based on routine requirement.
- Reporting and documenting the analytical data as per good laboratory practices and Good documentation practices.
- To maintain respective working area, documents, and records in auditable manner.
- To follow the safety, cGLP and cGDP in work area.
- To attend and complete the training activities whenever assigned.
- To ensure lab compliance during daily routine activities.
- Initiating events/change requests based on daily lab activities.
- Maintain a high standard of 5S practices at our workplace, through teamwork and self-discipline.
- Follow safety instructions at all times at the workplace. Should follow safety guidelines in the interest of self, environment and property and community at large.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
To perform the analysis of In-process sample, Hold Time , Finished product and stability samples, analytical testing based on routine requirement.
- Reporting and documenting the analytical data as per good laboratory practices and Good documentation practices.
- To follow the safety, cGLP and cGDP in work area.
- To attend and complete the training activities whenever assigned.
- To ensure lab compliance during daily routine activities.
- Initiating events/change requests based on daily lab activities.
- Maintain a high standard of 5S practices at our workplace, through teamwork and self-discipline.
- Follow safety instructions at all times at the workplace. Should follow safety guidelines in the interest of self, environment and property and community at large.
**Job Description**
To perform the analysis of In-process sample, Hold Time , Finished product and stability samples, analytical testing based on routine requirement.
- Reporting and documenting the analytical data as per good laboratory practices and Good documentation practices.
- To maintain respective working area, documents, and records in auditable manner.
- To follow the safety, cGLP and cGDP in work area.
- To attend and complete the training activities whenever assigned.
- To ensure lab compliance during daily routine activities.
- Initiating events/change requests based on daily lab activities.
- Maintain a high standard of 5S practices at our workplace, through teamwork and self-discipline.
- Follow safety instructions at all times at the workplace. Should follow safety guidelines in the interest of self, environment and property and community at large.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this job a match or a miss?
Apply Now
8
Analyst, Global Stability
Pudupakkam
Par Health
Posted 12 days ago
Job Viewed
Job Description
**Job Description Summary**
Experienced Analytical/Quality Control Analyst with 3-5 years of hands-on experience in an FDA-regulated pharmaceutical environment. Proficient in performing analytical testing of drug products and raw materials using techniques such as HPLC, GC, UV, and dissolution. Skilled in handling stability samples, method execution, data integrity compliance, and troubleshooting laboratory instruments. Strong understanding of cGMP, GLP, and FDA regulatory requirements, with a proven ability to ensure accurate documentation and compliance during audits and inspections.
**Job Description**
+ Perform routine and stability sample analysis as per approved specifications and test methods
+ Operate and maintain analytical instruments (HPLC, GC, UV, Dissolution Apparatus, etc.)
+ Review and document analytical data in compliance with cGMP and data integrity principles
+ Investigate OOS/OOT results and support deviation and CAPA activities
+ Ensure compliance with FDA, cGMP, and GLP requirements
+ Prepare and review analytical reports, protocols, and SOPs
+ Participate in method transfer, verification, and validation activities
+ Support regulatory and internal audits
**Key Skills:**
+ Strong knowledge of FDA regulations, cGMP, and data integrity
+ Analytical troubleshooting and problem-solving skills
+ Documentation and compliance expertise
+ Team collaboration and communication
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Experienced Analytical/Quality Control Analyst with 3-5 years of hands-on experience in an FDA-regulated pharmaceutical environment. Proficient in performing analytical testing of drug products and raw materials using techniques such as HPLC, GC, UV, and dissolution. Skilled in handling stability samples, method execution, data integrity compliance, and troubleshooting laboratory instruments. Strong understanding of cGMP, GLP, and FDA regulatory requirements, with a proven ability to ensure accurate documentation and compliance during audits and inspections.
**Job Description**
+ Perform routine and stability sample analysis as per approved specifications and test methods
+ Operate and maintain analytical instruments (HPLC, GC, UV, Dissolution Apparatus, etc.)
+ Review and document analytical data in compliance with cGMP and data integrity principles
+ Investigate OOS/OOT results and support deviation and CAPA activities
+ Ensure compliance with FDA, cGMP, and GLP requirements
+ Prepare and review analytical reports, protocols, and SOPs
+ Participate in method transfer, verification, and validation activities
+ Support regulatory and internal audits
**Key Skills:**
+ Strong knowledge of FDA regulations, cGMP, and data integrity
+ Analytical troubleshooting and problem-solving skills
+ Documentation and compliance expertise
+ Team collaboration and communication
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this job a match or a miss?
Apply Now
9