Position Asst. Manager QA

Qualifications & Requirements

Education: Bachelor or Master degree in Pharmacy (B.Pharm / M.Pharm / M.Sc.)

Experience: 6–10 years of experience in Quality Assurance within a regulated

pharmaceutical manufacturing facility (API).

Key Responsibilities:

Validation & Qualification Oversight:

• Validation Master Plan (VMP): Prepare, maintain, and update the site Validation

Master Plan to align with site objectives and current regulatory requirements (cGMP,

USFDA, EU-GMP, WHO, MHRA).

• Equipment Qualification: Review and approve Design Qualification (DQ), Installation

Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

protocols and execution reports for pharmaceutical production equipment.

• Utility & Facility Qualification: Review and approve qualification protocols and

reports for critical HVAC systems, purified water systems, compressed air, process

gases, cleanroom environments, and containment facilities.

• Computerized Systems & PLC Validation: Act as the Subject Matter Expert (SME)





for PLC, SCADA, and automated control systems on production equipment; ensure 21

CFR Part 11 and EU Annex 11 compliance.

• Cleaning Validation: Prepare, evaluate, and execute cleaning validation protocols,

sampling strategies (swab/rinse), analytical recovery studies, matrix calculations

(MACO), and summary reports.

• Thermal & Environmental Mapping: Oversee and review temperature and humidity

mapping activities across warehouses, cold rooms, stability chambers, and autoclaves,

including protocol preparation and final reporting.

Audits, Compliance & Vendor Management:

• Audit Compliance: Prepare response packages and CAPA tracking for external

customer audits, Corporate Quality Assurance (CQA) audits etc.

• Vendor Audits: Lead and execute risk-based audits of critical equipment

manufacturers, service providers, software vendors, and raw material suppliers.

📌 Assistant Manager- QA (Kolkata)
🏢 Asg Biochem
📍 Kolkata