DGM-Quality Assurance
1 Nos.
1134
Full Time
19.0 Year(s) To 20.0 Year(s)
20.00 LPA TO 24.00 LPA
Pharma / Biotech / Healthcare / Medical / R&D
Pharma/Biotech/Clinical Research
M.Sc / MS Science - Chemistry
Job Description:
- Position: - DGM QA
- Looking for candidates having 18-20 yrs exp in handling Plant QA - Change control, gap analysis OOS, Deviations & failure/Non-Conformance investigation, handled USFDA Audits, QMS implementation & automation.
- Education : M.Sc in Chemistry.
- Job Location: Aurangabad.
- Ensuring adequate quality assurance procedures usage for various processes of Cross-functional teams including that of QA.
- Review/Approval/Support for technical documents like Quality Assurance Procedures, Standard Operating Procedures (SOP), Quality Manual, Validation / Qualification Protocols, Formats, Batch Production Records, Master Formula Records, Bill of Materials, Packaging Operation Specifications & Process Flow Diagrams, Site Master File & Validation Master Plan.
- Final review of Executed batches and its relevant documentations, sample, QC results and release of FG batch to dispatch team with Product Release Certificate (PRC).
- Ensure adequate monitoring of batches in the shop floor with respect to Quality checkpoints like the In-process check, Line clearance, proper alignments to agreed process/procedure.
- Maintenance/management of Reference Samples meant for future record/reference.
- Ensure proper management of Change Control, Deviation and CAPA.
- Carrying out Vendor Audits and Audit of Contract Manufacturing Units.
- CANDIDATE HAS TO PAY. (COMPANY IS NOT GOING TO PAY)
Key Skills :
Company Profile
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