- Review & approval of all documents related to qc, stability management, cell bank qualification, MSAT in compliance to GMP and regulatory requirement. I.e. Sop/stp/ specification/protocol/report.
- Review/approval of analytical sections of annual product quality reports (APQR) for drug substance and drug product.
- Review of analytical sections of regulatory filings / current product registrations (global and domestic).
- Review /Approval of investigation reports (OOS, OOT, Deviations, Incidents)
- Facilitate timely completion of investigation & impact assessment for all analytical oos/oot/ deviation/ For commercial/non-commercial products.
- Review/Approval of various batch and stability analytical records in sap and LIMS.
- Responsible For document management, results review, material management and qms notification management in sap
- Govern the qa oversight for quality control area including electronic data review program
- Ensure shop floor GMP/GLP compliance in quality control area including stability management area.

📌 Senior Manager (Ahmedabad)
🏢 Intas
📍 Ahmedabad