Title:  Senior Executive

Qualification : BPharm /MPharm

Experience – 8+ years

Job Responsibilities:

1. Authorized to sign as a doer and verifier in:

• Batch Manufacturing Record, BMR Requisition, BMR Issuance Logbook.
• Protocols, Risk Assessment.

2. Authorized to sign as a checker/verifier in following document,

• Finished product logbook etc.

3. To prepare new BMR, revise BMRs within time.
4. To assist in preparation of Change Control, Corrective Action Plan & New Equipment’s preparation.
5. Handling of corrective and preventive action.
6. To ensure the compliance of various in-process control instructions provided in BMR, MBMR.
7. Preparation and updation of SOPs, BMRs, Log books, protocols and compliance thereof with training of people on the same.                                                

8. Handling and monitoring of Environmental monitoring system (EMS) system.
9. To maintain daily production report, machine utilization on day to day basis.
10. To learn EMS, review the report on daily basis. (Action, alert limit, breakdown maintenance).
11. Training to all technician & supervisor for new BMRs and revised BMRs to comply with the GMP.
12. To prepare process performance qualification/process validation protocols, study protocols.
13. To prepare failure mode effect analysis, risk assessment for product/process.
14. To undergo functional training, cGMP training or any other training identified as per schedule.
15. Any other responsibility assigned by department head after ensuring the relevant training status.