Sun Pharma Hiring For manager - Corporate Quality - CMO
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| Sun Pharma Hiring For manager - Corporate Quality - CMO |
Sun Pharma Job Vacancy Details:
Title: Manager
Location: Sun House - Corporate Office
Company: Sun Pharmaceutical Industries Ltd
Function : Corporate Quality - CMO
Designation : Manager
Qualification : M.Sc (Chemistry), B. Pharm or M. Pharm
Base Location : Mumbai
Experience : 8 to 10 years
Experience in handling of Quality management systems of CMO sites.
Release of finished products by review of batch related documents and release of Loan Licence products in SAP HANA.
Thorough knowledge of FSSAI, Schedule M and D&C act.
Perform periodic risk assessment of manufacturing sites.
Visits to contract manufacturing sites to ensure compliance as per cGMP & Sun Pharma Quality standards.
Preparation of site visit reports and ensure timely closure of discrepancies/gaps identified in the quality documents & systems in coordination with site Quality management.
Handling of product quality complaints. Conduct thorough investigation of complaints with RCA and appropriate CAPA. Monitor implementation & effectiveness of CAPA.
Preparation and review of BMR, BPR, PVP & R, Stability protocol, specification and STP.
Preparation and review of SOP’s as per global quality standards.
Assessment of impacted FG products/ Raw materials as per changes in monographs being reported in various Pharmacoepia from time to time. Track implementation of change at mfg. site.
Handling of QMS i.e CAPA, Change Control, Deviation, OOS,OOT, Vendor Qualification and Risk Assessment..
Handling of product transfers i.e. new product from R&D to CMO site, CMO to CMO site.
New product evaluation by thorough review of tech pack received from CMO sites.
Review and approval of artworks in Agile (Artwork management System).
Job demands travelling to CMO sites.
Usage experience of Documentum control manager (DCM), LIMS, Track Wise, EDMS, Agile (artwork management system) and SAP HANA is preferable.
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