Executive/ Senior Executive - Quality Assurance Bidar

1. To monitor the GMP activities and in case of any major observations in production block, warehouse, and engineering department with respect to GMP, the same to be highlighted to respective Department Head, Site Head and Site QA Head followed by ensuring that deviation is raised by concerned department.

2. To ensure the execution of validation programs like process validation, cleaning validation, periodic process verification, equipment/facility qualification etc. and execution of VMP.

3. To ensure the implementation of controlled documentation in all departments.

4. To ensure the proper implementation of CAPAs raised on the basis of deviations, investigations, customer complaints and audit response.

5. To review GxP documents in electronic as well as manual mode.

6. Preparation of Annual Review Reports of site products (wherever required).

7. To review the campaign reports, prepared by production or Process Engineering team (wherever required).

8. To verify and ensure that GMP Pro modules related to Production, Warehouse and Engineering department are On-line and no pending or open entry is there.

9. To participate and impart training like SOJT, UOJT, OJRT and SGMP, to shop floor personnel in all departments.

10. To comply with the SOP on Monitoring Mechanism by IPQA.

11. To prepare schedule for internal audits & conduct internal audits and participate in external audits as per schedule or based on the requirement.

12. To ensure that all departments are in state of compliance and all time ready for any audit by client or regulatory agencies.

1. To perform the job assigned by HOD/Site QA Head on daily/need basis.

2. To ensure that associates at shop floor are performing the checks during production to monitor and if applicable to adjust the process and/or that intermediates or finished goods are conforming to its specification.

3. To review and ensure that the yield verification of Intermediates and APIs is being performed by production associates and being reviewed by QA associates regularly.

4. To review/ensure that the sample verification/controls are followed in the manufacturing block, warehouse, and quality control against the standard operating procedures.

5. To provide line clearance to manufacturing block only after verification of related documents, controls, and area cleaning etc.

6. To review/ensure GMP compliance in production block, warehouse, engineering, and quality control department.

7. To monitor the sampling activities during intermediates and sampling of finished goods by Quality Control is performed in the presence of QA associates.

8. To ensure that sampled containers are sealed after sampling.

9. To review and ensure that BPRs are reviewed on-line randomly with respect to completeness, accuracy, and adequacy.

10. To review and ensure the adherence to preventive maintenance schedule.

11. To ensure that the weighing balances are being calibrated as per schedule and maintained in the state of compliance.

12. To review and ensure the on-line monitoring of various activities with respect to calibration of gauges, instruments and indicators is carried out as per schedule.

13. To communicate about any observation / deviation with respect to GMP to the Head of Department, Site Head and Site QA Head.

To ensure that clean room is in state of compliance with respect to SOPs on Operation and Maintenance of Clean Room, Entry & Exit Procedure in Clean Room and Clean Room Guidelines.