We are seeking an experienced Analytical Quality Assurance (AQA) qualified to ensure compliance of QC laboratory activities with cGMP, GLP, GDP, Data Integrity (ALCOA+), SOPs, and regulatory requirements.

The role will focus on analytical data review, OOS/OOT investigations, audit trail review, CAPA management, calibration and qualification compliance, and inspection readiness.

Key Responsibilities

- Review and investigate OOS, OOT, laboratory incidents, deviations, and CAPA.
- Perform analytical raw data review, chromatogram review, and verification of laboratory documentation.
- Conduct audit trail reviews and ensure compliance with Data Integrity (ALCOA+) requirements.
- Review calibration, qualification, maintenance, and computerized system compliance activities.
- Ensure compliance with cGMP, GLP, GDP, pharmacopoeial requirements, and regulatory guidelines.
- Support change controls, risk assessments, and laboratory compliance monitoring.
- Participate in internal,



customer, and regulatory audits and maintain inspection readiness.
- Monitor quality metrics, trend analysis, and recurring compliance issues.
- Conduct training and awareness programs on OOS/OOT, Data Integrity, GDP, GMP, and laboratory investigations.

Required Skills

- Strong knowledge of OOS/OOT investigations, Data Integrity, ALCOA+, Audit Trail Review, CAPA, Deviations, and Change Control.
- Hands-on experience with analytical instruments such as HPLC, UPLC, GC, UV, FTIR, Dissolution, TOC, ICP, and Karl Fischer.
- Knowledge of WHO-GMP, US FDA, EU GMP, 21 CFR Part 11, Annex 11, and ICH guidelines.
- Strong analytical, documentation, investigation, and problem-solving skills.
- Experience in pharmaceutical QC/QA laboratory compliance and regulatory inspections.

📌 Analytical QA Biosimilars (Nashik)
🏢 Reliance Life Sciences (RLS)
📍 Nashik