Analytical QA Biosimilars

We are seeking an experienced Analytical Quality Assurance (AQA) professional 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.