Senior Manager - QA
Intas Pharmaceuticals Ltd. · Ahmedabad · onsite · Posted 58d ago
Undisclosed15–20 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- 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.
Sourced from naukri
Skills
Cell bankootAPQREMAStabilitydeviationUSFDACAPAChange ControloosICHInvestigationMsatAQAAnalytical data reviewanalytical quality assuranceLab QaQMSQuality AssuranceAudit TrailEUGMPIncident
About Intas Pharmaceuticals
Intas Pharmaceuticals Ltd.
Pharma
17.4k+
employees
1977
49 years old
Ahmedabad, Gujarat
India
₹5.8L PA avg
Avg at Intas Pharmaceuticals
About
Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing organization in the world.
Industries
PharmaBiotech & Life sciences
Employee ratings
10 reviews
4.1/ 5
Culture
2.5
Career growth
2.4
Work-life
2.4
Employees rate it well for
Job Security41Overall Company41
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