08 Aug
|
Sun Pharmaceuticals
|
India
08 Aug
Sun Pharmaceuticals
India
**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, youll 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 others journeys. Key responsibilities: 1. Ensure compliancetocGMPs, safety production procedure, current SOPs, statutoryguidelinesandcompany'scode 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 giventime frameand within theallocatedresources. 4. Evaluating opportunities for reduction of waste generation and water wastage and fugitiveemission. 5. Ensuring availability andupdationof all relevantprocess, 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 validationprotocoland 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 ofrisk impact analysis, risk assessment &risk; re-assessment. 16.
Reviewing the trend of quality and productionparameterof 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 compliancetocGMPs, safety procedures, current SOPs, statutoryguidelinesand company code of conduct in the plant. 25. Training and development of subordinates and self-development. 26.Maintainingdiscipline, 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, analyticalimprovements. 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 prospect to grow, collaborate, and make a lasting impact. Lets 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)._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
📌 Manager - 1 (India)
🏢 Sun Pharmaceuticals
📍 India