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1. Responsible for indenting, approving and receiving of batch
production records and cleaning records and packing records as per production
requirement.
2. Responsible for raise the raw material indent and approving
of indented raw materials as per production planning.
3. Responsible for Maintain good Housekeeping in the plant
environment.
4. Responsible for coordinating with other departments to
maintain the execution of plant operations smoothly.
5. Responsible for updating the equipment status and allotted manpower
for effective utilization.
6. Responsible for initiating the indents i.e., procuring
production needs to run smooth production.
7. Responsible for execute all the schedules (Production
planning, Preventive maintenance, calibration etc.,) as per defined procedure.
8. Responsible for attending trainings like cGMP, On -Job and
safety as per the schedule.
9. Review of completed batch production records, log book / executed
records as per GDP.
10. To execute the process and online filling the BPR followed by
attained the knowledge of new products training before execution of the batch.
11. Responsible for preparation of all controlled documents relating to the quality of API’s and
intermediates. (Standard operating procedures, batch production records, forms,
protocols and reports etc.).
12. Responsible for initiation of QMS activities like change
control, deviation, OOS, investigation and CAPA.
13. Responsible for initiating of all type of validation
protocols, qualification protocols and reports including campaign reports
preparation.
14. To perform production operations as per the approved master batch
production record / cleaning record/ packing Activity.
15. Responsible for execution of all types of validations.
16. To extend support for customer audits / regulatory audits.
17. Any other Activity assigned by the Superior / HOD.
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