Job Description Summary

Job Description

1. To ensure the Segregation, storage and movement of dispensed materials.
2. Verification of dispensed materials before start of the operation.
3. Environmental monitoring as per the product specifications.
4. Execute production activities in a shift by managing available resources to achieve production target.
5. Maintain standard process parameters as per BMRs,BPRs and other supporting documents for achieving production target and maintaining quality.
6. Responsible for verifying online documentation against the electronic data available in the PLC, including events and alarms during the process. Ensure to verify specified vs actual data recording practices.
7. Initiation of Type A and Type B cleaning line clearances.
8. Responsible to perform the supervisor activities and all non-process area maintenance on requirement basis.
9. Minimize documentation error on shop floor.
10. Gap analysis of existing SOPs for further improvement.
11. To develop multi skilled personnel in the department for operations of equipment as well documentation.
12. Ensures that key points and decisions are regularly summarized, and it emphasizes the understanding of critical steps by technical staff throughout the meeting.

13. Ensure to prepare and distribute a detailed agenda before the meeting, outlining key topics and objectives and provide training to the operators daily for CAPA, recent events, DI,GDP and other relevant topics which will boost the awareness on DI for the smooth functioning of department with 100% compliance.
14. To maintain the area anytime presentable.
15. To coordinate with CFT.
16. To ensure maintenance & cleanliness of critical utilities (if applicable) as per procedures.
17. Ensure All manufacturing operations and related documentation updation as per BMR,BPR, SOP and cGMP & review of BMR, BPR.
18. Responsible for Validation, Qualification and Calibration of process or equipment's. Handling of all QMS documentation. 
19. Responsible for training for new joining, schedule and unscheduled department training.
20. Work with production teams to ensure cost-effective, high quality and timely delivery of products.
21. To carry out the activities whenever assigning by supervisor, shift in charge and management based on the company requirement.
22. By Monitoring and minimizing of  spillage and In process rejection shift wise and involved in  yield improvement program.
23. In process check in manufacturing and  packing operation.
24. Swab sample request submission to QC.
25. BMR & BPR reconciliation, batch review and closing.
26. Executed documents retrieval to QA.
27. Ensure and complete the equipment and instruments calibration, MP as per the schedule.
28. Ensure the area fumigation activity within the timeline.
29. Responsible for handling critical processes must oversee and guide activities such as recipe loading, binder addition, kneading, loading, AWC, and gun validation etc.
30. Responsible for being especially vigilant during manual operations where electronic data is unavailable and ensuring to witness critical activities such as granulation and sampling.
31. Review and approve all master documents.
32. Responsible for operational excellence include analyzing current operational processes,identifying inefficiencies and implementing changes to improve productivity and reduce costs.