API -Production

Job Summary:

This position is responsible for 100 % GMP compliance in the plant. This position is also responsible to prepare and review the BMR, ECR and all GMP documents and GMP related activities in the plant. Housekeeping maintenance and usage of PPE’s, Ensuring safe operation of his subordinates.                                                                      

Essential Job Functions:
 
1. Follow up the work based on priorities.
2. Monitoring and recording the critical process parameters as per BMR and Reactor wise TRT
    Control. Equipment cleaning as per requirements.
3. Following Good Manufacturing Practices during production activity.
4. Preparation/ Reviewing of all the documents (i.e.) BMR, ECR, Protocol, Template etc.
5. SAP related activities and maintaining stock as per the SAP HANA.
6. Wearing Personal protective equipment in the work premises.
7. Reporting about/Daily feedback process activity to seniors.
8. Follow up of online/ in- process/intermediate with QA/QC.
9. Raw material planning and Physical verification before charging.
10. Monitoring the usage of PPE’s in the work premises.
11. Ensure operational and product safety.
12. Maintaining Housekeeping in the production area.
13. Coordinating with other departments.
14. On the job training to subordinates.
15. Dispatch planning, following day to day basis.
16. Handling of GMP Related system software application. (i.e.) SAP, BRMS, LMS etc.
17. To co-ordinate and prepare the training related requirement and ensuring its compliance.