10 Quality Assurance Specialist jobs in Ankleshwar
Executive - Quality Control, Pharma
Posted today
Job Viewed
Job Description
Position Title: Executive – Quality Control
Qualification and Experience:
M. Sc (Organic / Analytical Chemistry) / B. Pharm with 2 - 6 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge
Job overview:
Responsibilities:
Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples.
Performing analysis of Stability, process validation samples, and Cleaning Validation.
Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc.
Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment.
Knowledge on the preparation of SOPs and Formats and Analytical Test records.
Managing reference standards, working standards, laboratory reagents & chemicals.
Arranging and observing Control Samples and maintaining the record.
Participating in the Investigation of out-of-specification results.
Maintaining laboratory raw data related to testing activity.
Performing Analytical Method validation, cleaning validation as per the protocol.
Coordinating with production and the warehouse for analytical activities
Compliance to HSE Requirements for QC laboratory.
Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations.
Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities.
Requirements
What makes this position unique?
Location information: Ankleshwar, Gujarat, India
Executive - Quality Control, Pharma
Posted today
Job Viewed
Job Description
Position Title: Executive – Quality Control
Qualification and Experience:
M. Sc (Organic / Analytical Chemistry) / B. Pharm with 2 - 6 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge
Job overview:
Responsibilities:
Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples.
Performing analysis of Stability, process validation samples, and Cleaning Validation.
Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc.
Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment.
Knowledge on the preparation of SOPs and Formats and Analytical Test records.
Managing reference standards, working standards, laboratory reagents & chemicals.
Arranging and observing Control Samples and maintaining the record.
Participating in the Investigation of out-of-specification results.
Maintaining laboratory raw data related to testing activity.
Performing Analytical Method validation, cleaning validation as per the protocol.
Coordinating with production and the warehouse for analytical activities
Compliance to HSE Requirements for QC laboratory.
Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations.
Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities.
Requirements
What makes this position unique?
Location information: Ankleshwar, Gujarat, India
Manager / Sr. Manager - Quality Control
Posted today
Job Viewed
Job Description
Job Title : Manager / Sr. Manager, Quality Control.
Qualification: Post Graduate in Science (Organic or Analytical Chemistry ) with 12 to 15 years of experience.
Job Summary :
Plan and implement Quality Control activity adhering to Zentiva Quality Guidelines, local FDA regulations, and HSE guidelines, leading a team of subordinates with optimum utilization of resources in order to ensure consistent good quality of products to meet with the GMP standards and customers’ requirements, living the Group’s Values and Code of Ethics. Strong leadership
KEY ACCOUNTABILITIES
Quality
Testing
HSE / IMS / GMP / GLP
Compliance
Training, People Management, and Industrial Relations
Coordination
Other
Manager / Sr. Manager - Quality Control
Posted today
Job Viewed
Job Description
Job Title : Manager / Sr. Manager, Quality Control.
Qualification: Post Graduate in Science (Organic or Analytical Chemistry ) with 12 to 15 years of experience.
Job Summary :
Plan and implement Quality Control activity adhering to Zentiva Quality Guidelines, local FDA regulations, and HSE guidelines, leading a team of subordinates with optimum utilization of resources in order to ensure consistent good quality of products to meet with the GMP standards and customers’ requirements, living the Group’s Values and Code of Ethics. Strong leadership
KEY ACCOUNTABILITIES
Quality
Testing
HSE / IMS / GMP / GLP
Compliance
Training, People Management, and Industrial Relations
Coordination
Other
Executive - Quality Assurance, Pharma
Posted today
Job Viewed
Job Description
Job Description
for Executive – Quality Assurance, PharmaEducational Qualification
Experience
Quality Management/Continuous Improvement
Line Clearance and shop floor compliance
Assisting in Complaint Investigation system at site
Assisting in Qualification and validation system, change control system, deviations
Preparing & review the Annual Product Quality Review
Review of Batch Manufacturing & Packing Records
Coordination of cGMP Training activity.
Compliance
Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by
Understanding the requirements Performing the Gap analysis to find out the gaps in existing system Preparing a compliance plan for closure of gaps Execution of compliance plans Review of completion for compliance activity Validations & Qualifications:
Ensure validated status of all equipment’s, manufacturing processes, and cleaning processes
Review of protocols for qualification and validation of facility/ equipment / product / process
Review of validation reports after execution of validation of facility /equipment / product / process
Documentation Control:
Preparation and Review of SOPs
Controlled distribution and archival of documents & record
Control of master documents
Assuring quality of products by :
Ensuring SOP compliance
Review of Batch Manufacturing & Packing Records
Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
Ensuring the effectiveness review of the implemented CAPA
cGMP Training :
To prepare training modules and organize training in GMP
Execute the training program in coordination with all concerned departments
Other:
Review of maintenance and calibration program
Executive - Quality Assurance, Pharma
Posted today
Job Viewed
Job Description
Job Description
for Executive – Quality Assurance, PharmaEducational Qualification
Experience
Quality Management/Continuous Improvement
Line Clearance and shop floor compliance
Assisting in Complaint Investigation system at site
Assisting in Qualification and validation system, change control system, deviations
Preparing & review the Annual Product Quality Review
Review of Batch Manufacturing & Packing Records
Coordination of cGMP Training activity.
Compliance
Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by
Understanding the requirements Performing the Gap analysis to find out the gaps in existing system Preparing a compliance plan for closure of gaps Execution of compliance plans Review of completion for compliance activity Validations & Qualifications:
Ensure validated status of all equipment’s, manufacturing processes, and cleaning processes
Review of protocols for qualification and validation of facility/ equipment / product / process
Review of validation reports after execution of validation of facility /equipment / product / process
Documentation Control:
Preparation and Review of SOPs
Controlled distribution and archival of documents & record
Control of master documents
Assuring quality of products by :
Ensuring SOP compliance
Review of Batch Manufacturing & Packing Records
Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
Ensuring the effectiveness review of the implemented CAPA
cGMP Training :
To prepare training modules and organize training in GMP
Execute the training program in coordination with all concerned departments
Other:
Review of maintenance and calibration program
Assistant Manager - Quality Assurance, Pharma
Posted today
Job Viewed
Job Description
Job Title: Sr. Executive / Assistant Manager – Quality Assurance, Pharma
Educational Qualification
Experience
Job Responsibilities & Accountabilities:
We are looking for an experienced QA professional to join our team and lead Deviation & Complaint Investigations, along with core QMS activities.
Key Responsibilities:
What We’re Looking For:
Be The First To Know
About the latest Quality assurance specialist Jobs in Ankleshwar !
Assistant Manager - Quality Assurance, Pharma
Posted today
Job Viewed
Job Description
Job Title: Sr. Executive / Assistant Manager – Quality Assurance, Pharma
Educational Qualification
Experience
Job Responsibilities & Accountabilities:
We are looking for an experienced QA professional to join our team and lead Deviation & Complaint Investigations, along with core QMS activities.
Key Responsibilities:
What We’re Looking For:
Job Title: Assistant Manager - Quality Assurance, Chemistry
Posted today
Job Viewed
Job Description
Job Title:
Assistant Manager - Quality Assurance, Chemistry
Education / Experience
M. Sc. Industrial Chemistry / B. Pharma / M. Pharma having 8 to 10 years in API industry with related experience in the following fields: QA, Manufacturing & GMP.
KEY ACCOUNTABILITIES
1. Quality Management/Continuous Improvement
Management and control of SOPs, Master documents, labels & other GMP impacted documents. Implementing necessary quality systems at the site including complaint Investigation, qualification and validation, change control, deviation and non-compliance management, documentation, supplier quality assurance etc. Out of specification & Out of trend investigation. Deviation Investigation. Incidence investigation. Review of Batch Manufacturing Records (BMRs), Analytical record & related documentation. Validation & Qualification. Change control review & management. Preparing the Annual Product Review and Annual Quality Review. Batch Rework/Reprocessing Approval. Approval of repacking, relabeling and non-standard batch size procedures as per applicable SOPs. Release/ rejection API & Intermediate. Conducting training program. Reviewing stability program. Review of Analytical method validation and qualification documents of Analytical instruments. Review of Equipment cleaning Records (ECRs). Issuance of all related GMP document. Compliance Ensure adherence to Corporate Quality Directives, Local FDA regulations by
Knowing the requirements
Performing Gap analysis and making a compliance plan for closure of gaps
Audit trail review
Supporting Regulatory Affairs in related documentation.
Prepare for and attend to external / regulatory quality audits.
Review of calibration and preventive maintenance program.
Review of work orders.
GMP round in plant.
Review of Stability Analytical documents.
Review of Audit Trail.
Validation:
Review of validation plans, protocols and reports.
Review of qualification plans, protocols and reports.
Documentation Control:
Preparations of quality system SOPs.
Review of other departmental SOPs.
To ensure controlled distribution and archival of documents and records.
Control changes in master documents and records through change control procedure.
Assuring quality of products by
Ensuring compliance with applicable SOPs
Management of deviation/failure investigations
By controlling the changes made to facility / equipment / product / process and master documents and records by following change control procedure
Investigation of customer complaints
By ensuring implementation of corrective and preventive actions proposed in deviation/failure investigations, audit / inspection compliance, and customer complaint investigations.
Training :
To develop cGMP training modules and impart training.
Coordination
QC (Pharmaceuticals-Ankleshwar): For testing of water for microbiological attributes, environmental monitoring, stability program & local regulatory compliance.
HR&A for training activity
Purchase (Mumbai and Ankleshwar): For co-ordination of supplier QA activities
IS – Ensure IS compliance in coordination with IS experts.
Other
Coordinating with various agencies for making of the quality agreements.
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
To support supplier quality assurance activity as needed.
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
To conduct Third parties audit as per company requirement.
To execute any special task allocated by Manager.
REQUIREMENTS
Technical skills &
Competencies / Language
Job Title: Assistant Manager - Quality Assurance, Chemistry
Posted today
Job Viewed
Job Description
Job Title:
Assistant Manager - Quality Assurance, Chemistry
Education / Experience
M. Sc. Industrial Chemistry / B. Pharma / M. Pharma having 8 to 10 years in API industry with related experience in the following fields: QA, Manufacturing & GMP.
KEY ACCOUNTABILITIES
1. Quality Management/Continuous Improvement
Management and control of SOPs, Master documents, labels & other GMP impacted documents. Implementing necessary quality systems at the site including complaint Investigation, qualification and validation, change control, deviation and non-compliance management, documentation, supplier quality assurance etc. Out of specification & Out of trend investigation. Deviation Investigation. Incidence investigation. Review of Batch Manufacturing Records (BMRs), Analytical record & related documentation. Validation & Qualification. Change control review & management. Preparing the Annual Product Review and Annual Quality Review. Batch Rework/Reprocessing Approval. Approval of repacking, relabeling and non-standard batch size procedures as per applicable SOPs. Release/ rejection API & Intermediate. Conducting training program. Reviewing stability program. Review of Analytical method validation and qualification documents of Analytical instruments. Review of Equipment cleaning Records (ECRs). Issuance of all related GMP document. Compliance Ensure adherence to Corporate Quality Directives, Local FDA regulations by
Knowing the requirements
Performing Gap analysis and making a compliance plan for closure of gaps
Audit trail review
Supporting Regulatory Affairs in related documentation.
Prepare for and attend to external / regulatory quality audits.
Review of calibration and preventive maintenance program.
Review of work orders.
GMP round in plant.
Review of Stability Analytical documents.
Review of Audit Trail.
Validation:
Review of validation plans, protocols and reports.
Review of qualification plans, protocols and reports.
Documentation Control:
Preparations of quality system SOPs.
Review of other departmental SOPs.
To ensure controlled distribution and archival of documents and records.
Control changes in master documents and records through change control procedure.
Assuring quality of products by
Ensuring compliance with applicable SOPs
Management of deviation/failure investigations
By controlling the changes made to facility / equipment / product / process and master documents and records by following change control procedure
Investigation of customer complaints
By ensuring implementation of corrective and preventive actions proposed in deviation/failure investigations, audit / inspection compliance, and customer complaint investigations.
Training :
To develop cGMP training modules and impart training.
Coordination
QC (Pharmaceuticals-Ankleshwar): For testing of water for microbiological attributes, environmental monitoring, stability program & local regulatory compliance.
HR&A for training activity
Purchase (Mumbai and Ankleshwar): For co-ordination of supplier QA activities
IS – Ensure IS compliance in coordination with IS experts.
Other
Coordinating with various agencies for making of the quality agreements.
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
To support supplier quality assurance activity as needed.
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
To conduct Third parties audit as per company requirement.
To execute any special task allocated by Manager.
REQUIREMENTS
Technical skills &
Competencies / Language