Assistant Manager – Laboratory Compliance

About the role

The Assistant Manager – Laboratory Compliance ensures that all activities in the Stability and Raw Material Laboratory meet current Good Manufacturing Practices (cGMP), pharmacopeial standards, and internal quality requirements. The role involves reviewing laboratory data, supporting software qualification, and driving continuous improvement.

Key responsibilities

• Maintain adherence to cGMP, Good Laboratory Practices (GLP), and data‑integrity standards.
• Review analytical reports and associated documentation for accuracy.
• Evaluate laboratory errors, Out‑of‑Specification (OOS) and Out‑of‑Trend (OOT) results and recommend corrective actions.
• Analyze non‑conformance data, create trend dashboards, and present findings.
• Ensure equipment software compliance and support audit readiness.
• Contribute to process‑improvement and laboratory‑efficiency initiatives.

Required profile

• M.Sc. or Pharm‑D from an HEC‑recognized university.
• 6‑8 years of experience in a pharmaceutical Quality Control laboratory.
• Strong understanding of laboratory functions, cGMP, and GLP requirements.
• Excellent analytical, documentation, and communication skills.

Required skills

• cGMP compliance
• Good Laboratory Practices (GLP)
• Data integrity management
• Analytical report review
• Out‑of‑Specification (OOS) investigation
• Out‑of‑Trend (OOT) analysis
• Dashboard creation and trend analysis
• Software qualification for laboratory equipment