Assistant General Manager Production

Job Responsibilities:

1. To see the production plan and workout accordingly.

2.To check the material availability accordingly as per monthly plans.

3.To ensure the proper handling, Issuance & return of change parts.

4.To review SOPs, SCPs, equipment master list and equipment qualification Plan.

5.To review the documentations such as IQ, OQ, PQ and validation protocols of newly procured equipment's with reports.

6.Implementation of production plan as per cGMP guidelines.

7.To read the communication book as per the plan and allocate the jobs to the operators & staff accordingly.

8.Making corrections in Draft of BPR copies of the running products and to participate in validation, calibration activities.

9.Approve the artwork of primary and secondary materials.

10. Approve the artwork of primary and secondary materials.e and approval of layouts.

Job Role:

Entire area Supervision

1.To follow the production plan and work accordingly.

2.To check BPR against SAP BOM and verify the quantity dispensed as per BPR.

3.To coordinate with and take follow-up from QA & QC Dept. regarding Line Clearance, in process checks, sample collection and its release for further process.

4.To coordinate with PM Store regarding dispensing of planned batches after communication with interlinked departments like packing, QA & PM store.

5.To ensure online SAP entries.

6.To maintain online documentation related to production activities like BPR, log books & daily records.

7.To ensure Preventive maintenance and calibration activities as per schedule on time.

8.Completion of BPR and all related documents & in process checks as per product status & requirement as defined in BPR in shift, effective manpower handling by proper allocation & maintaining the quality norms as per company policy.

9.To review the standard operating procedure, equipment master list, and equipment qualification plan as and when required.

10.To investigate the root cause of deviation in coordination with Quality Assurance after evaluation and deciding CAPA based on risk assessment and initiate any change by originating change control request after approval from all interlinked departments.

11.To comply with the requirement of technical audit.

12. Associate with contract giver during process validation and scale up batch in new products. 13. Identifying need and procurement of new equipment's, accessories and spares keeping productivity, quality and safety in mind.

14.To ensure the safety of personnel, product and equipment before & during operation.

Documentation Packing

1.To follow the production plan and work accordingly.

2.To train the pharmacist and workmen in the concerned area as per SOP.

3.To coordinate with and take follow-up from QA & QC Dept. regarding Line Clearance, in process checks, sample collection and its release for further process.

4.To coordinate with PM Store regarding dispensing of planned batches after communication with interlinked departments like packing, QA & PM store.

5.To ensure online SAP entries.

6.To maintain online documentation related to production activities like BPR, log books & daily records.

7.To ensure Preventive maintenance and calibration activities as per schedule on time. 8.Completion of BMR and all related documents & in process checks as per product status & requirement as defined in BPR in shift, effective manpower handling by proper allocation & maintaining the quality norms as per company policy.

9.To review and maintain equipment qualification documents such as URS, DQ, IQ, OQ, PQ and assist QA/R & D/Regulatory Department etc. in finalization of Validation protocol and report by review of summary of Product Validation data for incorporation of critical product process parameters.

10.To review & revise BPR, MFR, SOP and formats as and when required.

11.To review and revise standard operating procedure, equipment master list, and equipment qualification plan as and when required.

12.To investigate the root cause of deviation in coordination with Quality Assurance after evaluation and deciding CAPA based on risk assessment and initiate any change by originating change control request after approval from all interlinked departments.

13.To comply with the requirement of technical audit.

14.To Identifying need and procurement of new equipment's, accessories and spares keeping productivity, quality and safety in mind.

15.To ensure the safety of personnel, product and equipment before & during operation.

General Work Production Supervision

1.To follow the production plan and work accordingly.

2.To check BMR against SAP BOM and verify the quantity dispensed as per BMR.

3.To train the pharmacist and workmen in the concerned area as per SOP.

4.To coordinate with and take follow-up from QA & QC Dept. regarding Line Clearance, in process checks, sample collection and its release for further process.

5.To coordinate with PM Store regarding dispensing of planned batches after communication with interlinked departments like packing, QA & PM store.

6.To ensure online SAP entries.

7.To maintain online documentation related to production activities like BMR, log books & daily records.

8.To ensure Preventive maintenance and calibration activities as per schedule on time. 9.Completion of BMR and all related documents & in process