Title:  Manager - 1

Job Title:

Manager

Business Unit:

Production

Job Grade

G11A

Location :

Toansa

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Key responsibilities:

1.  Ensure compliance to cGMPs, safety production procedure, current SOPs, statutory guidelines and company's code of conduct. 

2. Ensuring delivery of scheduled production as per the plan meeting quality and cost parameter. 

3. Ensuring that all the projects are completed in the given time frame and within the allocated resources. 

4. Evaluating opportunities for reduction of waste generation and water wastage and fugitive emission. 

5. Ensuring availability and updation of all relevant process, regulatory, statutory, engineering documents in the module. 

6. Ensuring production activities are performed as per approved written down procedure. 

7. Ensuring the cost of manufacturing is within standard yields & usages and continuous effort to decrease the product cost. 

8. To ensure simplification and improvement of present manufacturing processes through continuous development work. 

9. Issuance of the Batch Production Records & batch record of cleaning (BRC) for production of intermediates or APIs according to current SOPs. 

10. Reviewing all Batch Manufacturing Records & Equipment cleaning records and ensuring that these are completed and signed. 

11. Review of new/revised MPRs. 

12. Review of new/revised BMRs and validation protocol and reports. 

13. Performing authorized SAP track wise CAPA, LMS & DCM activities relevant to the job profile. 

14. Reviewing & approving of SOPs as assigned. 

15. Reviewing of risk impact analysis, risk assessment & risk re-assessment. 

16. Reviewing the trend of quality and production parameter of intermediates & APIs. 

17. Ensuring that all production deviations are evaluated and all critical deviations are investigated as per current SOPs. 

18. Investigating OOT, OOS & market complaints of intermediates & APIs and conclusions are recorded on time. 

19. Planning & implementation of CAPA actions arising from investigations, observations, risk assessments & regulatory observations. 

20. Ensuring that all production deviations are evaluated and investigated as per current SOPs. 

21. Ensuring timely maintenance of equipment & facility and records are maintained. 

22. Evaluating the proposed changes in the product, process and equipment for quality and productivity improvements. 

23. Qualifying new or modified facilities and equipment as per current SOPs. 

24. Ensuring compliance to cGMPs, safety procedures, current SOPs, statutory guidelines and company code of conduct in the plant. 

25. Training and development of subordinates and self-development. 

26. Maintaining discipline, morale, motivation of employees and harmonious industrial relations. 

27. Ensures verification of document destruction records prepared by the document coordinator. 

28. Preparation and maintenance of annual budget for plant. 

29. Review of Product Development Report (PDR) and Cleaning Procedure Development Report (CPDR). 

30. Review and revision of product manuals. 

31. To sign off documents/track-wise records as HOD/Function Head. 

32. To manage solvent recovery operations at site through common solvent recovery group. 

33. To ensure necessary maintenance completion in plant. 

34. To ensure upkeep of plant for inspection readiness. 

35. Conducting internal reviews and visits of plants for compliance. 

36. Developing risk management strategies and performing assessments for business continuity. 

37. Handling documentation cell team and setting priorities. 

38. Concluding OOS/OOT/UPD investigations with cross-functional teams. 

39. Conducting primary investigations and shop floor review. 

40. Review of investigation drafts and CAPA discussions. 

41. Leading operational excellence activities. 

42. Handling site issues on cost, inventory, process, analytical improvements. 

43. Coordinating with QA for audits and responses. 

Travel Estimate

Job Requirements

Educational Qualification

M.Sc. (Chemistry)

Experience

Tenure:  10 - 15 Years in API Plant, Strong knowledge of cGMP, FDA regulations, and industry best practices

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).