India · Internship
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Trainee Operative Technician :
1. Senior Operator to Apprentice-Manufacturing shall report to Sr. Officer to Jr. Officer-Manufacturing.
2. Responsible for cleaning and operation of equipment, instruments as per respective Standard Operating Procedure (SOP).
3. Responsible for performing manufacturing operations as per respective BMR.
4. Responsible for performing in process tests as per respective BMR.
5. To record the entries in BMR, Equipment logs and various formats on line as per respective procedures.
6. Responsible for performing the calibrations of equipment like weighing balances as per Schedule and to maintain records for it.
7. To return extra materials to warehouse department.
8. Responsible for status labeling of equipment, accessories and in process materials.
9. To label and arrange the in process materials, finish product as per respective BMR.
10. To follow the safety practices (PPE) in production department.
11. To handover production activities/plan to the next shift person.
12. To follow the procedures with the requirements of current Good Manufacturing Practice (cGMP).
13. To give break down request to maintenance department.
14. To give technical information sheet to QC department.
15. To update status board of process cubicles as per the process activity.
16. Responsible for area cleaning and sanitization in production department.
17. Responsible for conducting predictive and preventative maintenance with engineering department.
18. Maintain punctuality and discipline to reach & start work within time.
19. All time readiness for internal and external regulatory audit and compliance.
20. Keep and maintain 5s in the area.
21. To follow the gowning and de-gowning practices in production department.
22. Follow pre-start up activity during manufacturing and ensure area cleanness with respect to foreign particle (fiber/hair).
23. Issuance & retrieval of documents.
24. To update the status of PM & re-qualification of equipment.
25. To be responsible to take part and give input & suggestion for quality and compliance monitoring - QMS elements ( Change control , Deviation, OOS, OOT, Incident, CAPA, Complaints, QRM etc.).
26. To ensure the compliance on Data integrity, GMP, GDP.
27. To follow the safety compliance in production department.
28. To ensure completion of necessary /assigned SOP/module/quality event based trainings before initiating GMP work.
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