Officer

Job Summary

• 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 new 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.