Senior Manager - QA

Intas; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Intas in Ahmedabad seeks a QA professional to review and approve QC, stability management, MSAT, and related GMP/regulatory documents, ensuring accuracy and compliance.

The role includes reviewing APQR analytical sections, regulatory filings, and investigation reports, while governing electronic data review and QMS notifications in SAP/LIMS, and ensuring shop floor GMP/GLP standards in QC and stability areas.

Responsibilities

• Review & approval of all documents related to QC, stability management, cell bank qualification, MSAT in compliance to GMP and regulatory requirements (SOP/STP/specification/protocol/report).
• Review/approval of analytical sections of APQR for drug substance and drug product.
• Review of analytical sections of regulatory filings / new 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.

Job description

• 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 / new 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.