1. To ensure good House keeping in the production area and surrounding area of the plant.
2. To ensure that products are produced and stored accordingly to the appropriate documentation in order to obtained the required quality.
3.To approve the instruction relating to production operations and ensure their strict implementation.
4. To ensure training to the subordinates on cGMP practices, SOP's, BMR, ECR, Safety practices, documentation as training coordinator.
5. To monitor the production activity on day to day basis and prepare production report.
6. To ensure the production records are evaluated and signed by an authorized person.
7. Ensure the product is manufactured as per BMR with standard quality and yield
8. To achieve the monthly production target as per plan
9. To co-ordinate with the other departments on daily basis and resolve the issues
10. To co-ordinate with Engineering department to adhere preventive maintenance schedule.
11. To ensure the qualification and maintenance of production department, premises and equipments.
12. Monitor the standard TRT Vs Actual TRT
13. Monitor the water consumption/ waste generation like Solid , Liquid etc on day to day basis
14. To ensure the safety equipments are in working condition
15. To prepare failure investigation reports and take necessary corrective / preventive action.
16. To review and approve the validation/ qualification protocols and reports and ensure the proper execution of the same.
17. To review the daily plant activity/ records etc. and instruct the plant people accordingly.
18. Continuously monitor and review process and operation and give suggestion for cost reduction and quality improvements.
19. To ensure that production data are entered in Metis system regularly.
20. To review inventory of RM and PM as per production plan and if required to coordinate with supply chain department for timely receipt of the same.
21. To co-ordinate with HR department for recruitment of the new person as per plant requirement
22. To follow instruction received from superior.
23. To inform superior in case of abnormality observed by him in plant and process.
24. To ensure that Change control are properly filled and changes are implemented as per SOP.
25. To monitor product quality and yields. To investigate in case of deviation from standards.
26. Preparation and review of BMR, ECR and SOPs and other cGMP related documents.
27. To carried out investigation of market complaint.
28. To carried out product Recall management.
29. To comply daily plant round observation.
30. To handle the LIMS for the investigation and new product documentation purpose.
31. Monitored and Printout the production data from Data logger system regularly.
Job Location - Dahej
- Master of science in Chemistry/BE /Diploma chemical Exposure of risk management will be an added advantage Technology know how (knowledge of SAP will be an added advantage) Compliance management (knowledge of cGMP and regulatory guideline will be an added advantage) People developer Execution focus Process excellence Accountability Collaboration
- Minimum 15 to 20 years of experience in API Pharmaceutical industry
Salary: Not Disclosed by Recruiter
Employment Type:Full Time, Permanent
Desired Candidate Profile
PG:MS/M.Sc(Science) - Chemistry
Sun Pharmaceutical Industries Ltd
Contact Company:Sun Pharmaceutical Industries Ltd