Quality Assurance (QA) In-Charge

Designation - Quality Assurance (QA) In-Charge
Industry - PharmaceuticalExperience:6–7 Years (QA Department – OSD Manufacturing: Tablets & Capsules)

Jejuri / Pune, Maharashtra

Qualification:

B.Pharm / M.Pharm / M.Sc. (Chemistry / Microbiology)

Key Responsibilities

1. Documentation and Record Control

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

2. In-Process Quality Assurance (IPQA)

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

3. Deviations, Change Control & CAPA

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

4. Validation & Qualification

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

5. GMP Compliance & Audits

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

6. Training & Quality Culture

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

7. Batch Release

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

Job Type: Full-time

Pay: ₹40,000.00 - ₹70,000.00 per month

Benefits:

• Health insurance
• Provident Fund

Ability to commute/relocate:

• Pune, Maharashtra: Reliably commute or planning to relocate before starting work (Required)

Education:

• Master's (Preferred)

Experience:

• Pharmaceutical: 3 years (Required)
• total work: 7 years (Preferred)
• QA: 5 years (Required)

Work Location: In person