Quality Assurance Manager (Pharma)

Designation - Quality Assurance Manager (Pharma)

Experience - 6–7 Years (QA Department – OSD Manufacturing: Tablets & Capsules)

Salary - 50000 -100000 Monthly

Location - Jejuri, Maharashtra, India

Qualification - B.Pharm / M.Pharm / M.Sc.

Key Responsibilities

1. Documentation and Record Control

1. Review and approve Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
2. Control, issue, and retrieval of SOPs, formats, logbooks, and quality documents.
3. Maintain and update the Master Manufacturing Formula (MMF) and Standard Operating Procedures (SOPs).
4. Ensure data integrity and compliance with GDP (Good Documentation Practices).

2. In-Process Quality Assurance (IPQA)

1. Provide line clearance for all manufacturing and packing operations (dispensing, granulation, compression, coating, and packing).
2. Perform and monitor in-process checks (weight variation, hardness, thickness, disintegration, friability).
3. Ensure online documentation and traceability of all manufacturing activities.
4. Ensure environmental conditions and hygiene are maintained during production.

3. Deviations, Change Control & CAPA

1. Investigate and document deviations, OOS, OOT, and market complaints.
2. Execute and monitor Corrective and Preventive Actions (CAPA).
3. Review and manage Change Control requests in coordination with Production & QC.

4. Validation & Qualification

1. Participate in process validation, cleaning validation, and equipment qualification (IQ, OQ, PQ).
2. Review validation protocols and reports to ensure scientific and regulatory accuracy.

5. GMP Compliance & Audits

1. Conduct routine GMP inspections and ensure compliance in all departments.
2. Prepare and face regulatory, WHO, and customer audits.
3. Ensure timely closure of audit observations with effective CAPA implementation.

6. Training & Quality Culture

1. Conduct internal GMP, GDP, and hygiene training sessions.
2. Support quality improvement initiatives and maintain good documentation culture.

7. Batch Release

1. Review of QC analytical results and production records for final batch release.
2. Ensure that only approved materials and validated equipment are used. Skills & Competencies
3. In-depth knowledge of cGMP, WHO, GLP, GDP practices.
4. Experience with OSD (Tablet & Capsule) manufacturing processes.
5. Strong analytical, documentation, and communication skills.
6. Ability to lead and mentor QA executives/officers.
7. Audit handling and cross-functional coordination abilities.