Asst. General Manager - QA

Job Description:

Position:        Asst. General Manager - QA

Location:       Ahmedabad

Experience:    20 - 25 Years

Industries:      Pharma     

Responsibilities:

• Strategic & Compliance Oversight:
• Oversee QA systems for biosimilars and sterile manufacturing including vaccines, insulin, and injectables.
• Ensure adherence to GMP, ICH Q8-Q10, WHO TRS, USFDA, EMA, and other global regulatory standards.
• Serve as the site QA lead during regulatory inspections and audits (USFDA, EU GMP, WHO, etc.).
• Lead Quality Risk Management (QRM) and Continual Improvement initiatives.
• Review and approve:
• Batch Manufacturing Records (BMR)
• Batch Packaging Records (BPR)
• Validation protocols and reports (Process, Cleaning, Hold Time, Media Fill, etc.)
• Change controls, deviations, CAPA, and OOS/OOT investigations.
• Oversee sterility assurance activities and aseptic processing compliance.
• Ensure effective data integrity practices throughout the QA operations.
• Lead QA shop floor monitoring for sterile areas (Grade A/B/C/D).
• Documentation & QMS:
• Ensure proper implementation and review of Quality Management System (QMS).
• Oversee documentation control including SOPs, protocols, and quality manuals.
• Manage training programs for QA and cross-functional teams on GMP and regulatory updates.
• Cross-functional Collaboration:
• Coordinate with Manufacturing, QC, RA, Validation, Engineering, and Supply Chain to ensure QA compliance.
• Participate in cross-functional meetings related to Tech Transfer, Scale-up, and Commercial Manufacturing.
• Team Management:
• Lead and mentor a team of QA professionals.
• Develop and drive performance management, training, and career development plans.

Required Skills:

• Strong knowledge of sterile manufacturing, aseptic techniques, and cleanroom classifications.
• Expertise in handling QA for vaccines, insulin, biosimilars, and other biologics.
• Hands-on experience in regulatory inspections and robust QMS implementation.
• Analytical thinking, leadership, and people management skills.
• Excellent documentation, communication, and presentation abilities.

Required Qualification: - B.Pharm/M.Pharm

Salary :- Upto 50.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-