Assistant Manager Analytical Quality Assurance

Job Title: Executive / Sr. Executive – Analytical Quality Assurance (AQA)Industry: Pharmaceuticals (Formulation)Department: Quality AssuranceJob Summary:

We are looking for a detail-oriented Analytical Quality Assurance professional to ensure compliance and oversight of analytical activities in a GMP-regulated pharmaceutical environment. The role involves review of analytical data, validation oversight, documentation compliance, and ensuring data integrity across QC operations.

Key Responsibilities:

• Review and approve analytical data, test reports, and certificates of analysis (CoA)
• Ensure compliance of QC laboratory activities with GMP, GLP, and regulatory guidelines
• Review of analytical method validation, method transfer, and verification documents
• Oversight of stability studies, protocols, and reports
• Review of calibration and qualification records of analytical instruments (HPLC, GC, UV, etc.)
• Ensure data integrity compliance (ALCOA+ principles) in all analytical records
• Review and approval of SOPs, specifications, protocols, and reports
• Handle deviations, OOS (Out of Specification), OOT (Out of Trend), CAPA, and change controls
• Participate in internal, external, and regulatory audits and ensure audit readiness
• Coordinate with QC, Production, and Regulatory teams for compliance and quality improvements

GMP & Compliance Responsibilities:

• Ensure adherence to GMP, GLP, and regulatory requirements (USFDA, WHO, MHRA, etc.)
• Maintain proper documentation and traceability of all analytical activities
• Support regulatory inspections and client audits
• Ensure implementation of quality systems and continuous improvement

Key Skills:

• Analytical QA Review
• GMP / GLP Compliance
• Data Integrity (ALCOA+)
• OOS / OOT Investigation
• Method Validation & Transfer
• Audit Handling
• Documentation & Compliance

Eligibility Criteria:

• Qualification: M.Sc / B.Sc (Chemistry / Analytical Chemistry) / B.Pharm / M.Pharm
• Experience: 2–6 years in Analytical QA / QC with QA exposure in pharma industry

Preferred Candidate Profile:

• Strong experience in data review and documentation
• Exposure to regulatory audits (USFDA, WHO, EU, etc.)
• Good understanding of analytical instruments and laboratory practices
• Strong attention to detail and compliance mindset