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Senior Manager Production
1 week ago
Position: Production QMS (Sterile)
Job Grade - Senior Manager
Qualification: B.Pharma/M.Pharma.
Experience: Minimum 15+ years.
Job Location : Baska (Gujarat)
Job Role : Sr.Manager Production (QMS)
Responsibilities:
- Proficient in production planning, batch manufacturing, filling operations, sterilization activity, lyophilized activity & visual inspection.
- To review and maintain production schedule as per the project/priority and as per the availability of the required material & all other related resources.
- To review and approve documents through QMS software if applicable
- To review the document like MF, BMR (Batch Manufacturing Record), BOM (Bill of Material)
- Exposure of independently leading & facing regulatory inspection.
- Setting & achieving production targets.
- Optimum utilization of man, material to achieved production targets.
- Strong knowledge of QMS.
- Handling CAPA, CCR, Deviation.
- Review of BMR, SOP, OOS, OOT, Risk Management
- Review of validation protocols.
- Preparation & review of URS, IQ, OQ, PQ, area qualification, media fill, and fumigation.
- OPEX monitoring and CAPEX preparation.
- Experience in process simplification & implementation of improvement projects.
- Knowledge of SAP, CCR, deviation, CAPA, LMS, track wise.
- Strong people management skills.
