Exp - 5+ years Qualification: B.Pharma /M.Pharma/MscJob Responsibilities:
- Authorized to sign as a doer and verifier in:
- Batch Manufacturing Record, BMR Requisition, BMR Issuance Logbook.
- Protocols, Risk Assessment.
- Authorized to sign as a checker/verifier in following document,
- Finished product logbook etc.
- To prepare new BMR, revise BMRs within time.
- To assist in preparation of Change Control, Corrective Action Plan & New Equipment’s preparation.
- Handling of corrective and preventive action.
- To ensure the compliance of various in-process control instructions provided in BMR, MBMR.
- Preparation and updation of SOPs, BMRs, Log books, protocols and compliance thereof with training of people on the same.
- Handling and monitoring of Environmental monitoring system (EMS)
system.
- To maintain daily production report, machine utilization on day to day basis.
- To learn EMS, review the report on daily basis. (Action, alert limit, breakdown maintenance).
- Training to all technician & supervisor for current BMRs and revised BMRs to comply with the GMP.
- To prepare process performance qualification/process validation protocols, study protocols.
- To prepare failure mode effect analysis, risk assessment for product/process.
- To undergo functional training, cGMP training or any other training identified as per schedule.
- Any other responsibility assigned by department head after ensuring the relevant training status. "
📌 Manager - 2 (Alipur)
🏢 SUN PHARMA
📍 Alipur
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