Assistant Manager- QA

ASG Biochem Pvt Ltd; Kolkata District; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

ASG Biochem Pvt Ltd in Kolkata is seeking an Assistant Manager QA with 6–10 years of experience in a regulated pharmaceutical manufacturing environment. The role emphasizes ensuring product quality, compliance, and robust validation activities.

You will lead validation activities, review DQ/IQ/OQ/PQ, oversee PLC/SCADA validation, manage audits and CAPA, and coordinate vendor assessments to uphold cGMP standards.

Qualifications

• 6–10 years of QA experience in a regulated pharma manufacturing facility.
• Exposure to cGMP, USFDA, EU-GMP, WHO, MHRA in audits and validation.
• Strong understanding of validation life cycle (VMP, DQ/IQ/OQ/PQ).
• Experience with computerised systems validation (21 CFR Part 11 / EU Annex 11).
• Leadership of audits, CAPA tracking, and vendor management.

Responsibilities

• Oversee Validation Master Plan and keep it aligned with regulatory requirements.
• Review and approve DQ/IQ/OQ/PQ protocols and execution reports for production equipment.
• Validate utilities and critical HVAC, water systems, cleanrooms, and containment facilities.
• Lead PLC/SCADA validation and assure 21 CFR Part 11 compliance.
• Develop and execute cleaning validation protocols and related studies.
• Manage thermal and environmental mapping across warehouses and autoclaves.
• Coordinate audits and CAPA tracking; support vendor audits and risk assessments.

Skills

Quality Assurance

Regulatory Compliance

Validation Expertise

GMP Knowledge

Audit Readiness

Education

B.Pharm / M.Pharm / M.Sc. (Pharmacy)

Job description

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.