8 Quality Control Manager jobs in Ankleshwar

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

Job Description

Educational 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

Job Description

Educational 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

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: 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

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

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