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 / recent 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 Qa Ahmedabad
🏢 Intas
📍 Ahmedabad