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6 hours ago
Department
- ANKLESHWAR QA -U2
- Job posted on
- Feb 12, 2025
- Employment type
- C-C8-Confirmed-HO Executive
Total Experience - Minimum 4 Years
- Person from background of**Quality Control**department**will be more preferable.
- Responsible to ensure Good Laboratory Practices & compliance of QC SOP.
- Responsible for reviewing and approving the analytical reports Intermediate, Drug Intermediate, Drug Substance, stability report, Stability Protocol, Stability trend and instrument calibration.
- Responsible for reviewing and approving the stability & API analytical reports.
- Responsible for reviewing and approving the Working, Reference standard and COA.
- Responsible for issuance and retrieval of the controlled documents related to QC.
- Responsible to review Audit trails in the Laboratory software’s.
- Responsible to review user access privileges of instrument and compliance with requirements.
- Coordinate and provide documents pertaining to Drug Master File (DMF) filings.
- Responsible for review of specifications and standard testing procedure.
- Responsible for reviewing and approving of the Laboratory Instruments/ Equipment’s calibration.
- Responsible for technology transfer and related activities.
- Responsible for review of Stability summary trend.
- Responsible review of Risk Assessment report.
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