Sr. Manager/Manager - Prod. SVP

Job Description

1. To review and implement Quality Management System for cGMP compliance at Production SVP plant. 2. To review and approval of BMR, BPR in Caliber BRM software. 3. Handling of Caliber QAMS, DMS, Nichelon 5 CMS, Dynamic, serialization & aggregation. 4. Giving the required training, also responsible for Media fill and GMP compliance. Handling of Quality Risk Management (QRM). 5. Responsible for Job allocation of Production Team. 6. To ensure the GMP at all level in the SVP plant. 7. To review and approval of production documentation for compliance with cGMP requirements. 8. To prepare & review SOPs, Validation Protocols, Master Batch Production Records and other related documents at Production SVP plant. 9. To review Change Control, Incident /Deviations and ensure its closure, within given timeframe as per respective SOP. 10. Review signatory for all SOPs, Master Batch Records, Qualification, Validation, documents of Analytical, APQR and Manufacturing equipment, Specifications, Change Control, OOS investigations and other investigations. 11. To coordinate with warehouse team for ensuring the availability of raw material and packing material. 12. Ensure the execution of Process validation and equipment validation. 13. To review batch production Records, to assure that the batch has been manufactured and tested as per laid down procedure / specification. Deviation if any, are recorded, investigated. 14. To conduct and monitor calibration, qualification, validation and requalification activity at site. 15. To ensure release (approval of rejection) the batch manufactured at site. 16. To review product License Application and support Regulatory department, obtaining the product license from the local Regulatory Authority. 17. To review and submit the data / information to Regulatory Affairs for preparation of DMF/dossiers/application for registration of the product with Regulatory Authority of the countries, intended to market the product. 18. To inform top Management on quality issue (if any). 19. Ensure the compliance with online dispensing, manufacturing, filling, sealing, Visual Inspection and packing activities. 20. To ensure implementation of the CAPA initiated as a result of self-audit, customer, regulatory audit in Production. 21. Participation and monitoring all activities of small volume parenteral (SVP) project in coordination with CFT like QA, QC, Engg and warehouse dept. 22. Review and approval of all documents pertaining to small volume parenteral facility. 23. Responsible for Aseptic behaviour in Aseptic area. Interested candidates can share their resme on dipika.parmar@milanlabs.com