Source description
About the role
- To monitor and coordinate all contract manufacturing activities as per production planning. 2. For the products manufactured at contract manufacturing site: A. Periodic stock verification to control material inventory. B. To review & verify stock statement provided by contract manufacturer with every batch delivery. C. To get tentative delivery schedule and production planning from contract manufacturer. D. To verify the drums are sealed properly as per seal number provided by the contract manufacturer. 3. Daily co-ordination with contract manufacturers for production activity at contract manufacturing sites. 4. Daily status updation against Monthly Production Planning for contract manufacturing sites. 5. Identification of suitable and cost effective new contract manufacturing sites. 6. Up keep the existing agreements as per validity and new/ renewal of agreement. 7. Preparation of Batch Manufacturing Record (BMRs) for contract manufacturing. 8. Preparation of standard operating procedures (SOP’s) for contract manufacturing. 9. Preparation and review the contract manufacturing project process validation, cleaning validation and technology transfer reports. 10. Technology transfer coordination at Contract manufacturing in all respect i.e. Production, QC, QA, etc. 11. Pre Technology transfer report preparation for contract manufacturing activity. 12. Trouble shooting if any, in Process & Operation at Contract manufacturing site resolve coordination with other department for change control, deviation, etc. 13. To monitor & review the quality & quantity (yield) of the Product Manufactured at Contract manufacturing site. 14. Process Optimization, Cost Reduction & Yield Improvement for contract manufactured products. 15. To ensure Safety & GMP compliance at contract manufacturing sites. 16. Internal and external audit at contract manufacturing and Navi Mumbai coordination and its compliance. 17. To prepare quality risk management of all products manufactured at contract manufacturing. 18. Review of batch manufacturing records of contract manufacturing sites and submission to QA. 19. Internal customer’s response related contract manufacturing site/Product querry.
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