SUN PHARMA LTD - Openings for CMO – QA (M.Sc, B.Sc, M.Pharm, B.Pharm Candidates)

Manager - CMO – QA @ Sun Pharmaceutical Industries Ltd

Job description

• Responsible for review of batch related documents and release of Loan Licence products (Contract Manufacturing sites).
• Preparation & review of specs and stp in DCM/LIMS.
• Review of FG artworks.
• Handling of deviations, change controls, OOS & OOT.
• Visits to contract manufacturing sites to monitor manufacturing and testing is performed as per Sun Pharma Quality standards.
• Preparation of visit report and ensure closure of discrepancies/gaps identified in the documents & system in coordination with site Quality management.
• Participate in technology transfer along with FDD & MSTG. Review of validation data required to prepare validation report.
• Preparation and review of stability protocol.
• Monitoring ongoing stability study of LL products at contract manufacturing sites.
• Product complaints are logged and communicated timely to respective contract manufacturing sites.
• Thorough investigation of complaints with RCA and appropriate CAPA.
• Participate in Investigation of critical and repetitive complaints along with site quality team.
• Monitor implementation of CAPA as per committed timeline and effectiveness of CAPA.
• Initiate quality alert and coordination with internal stakeholders to expedite the recall closure with appropriate documentation.
• Evaluation /Assessment of impacted FG products/ Raw materials as per changes in monographs being reported in various Pharmacopeia from time to time. Track implementation of change at mfg. site.
• Review of Product documents like BMR/BPR, FG test report, stability data, Process Validation Report, Analytical method validation report, APQR and etc.
• Work experience on SAP, Trackwise, AMS, LIMS and DCM
• 10-15 days travel in a month (average) to various contract manufacturing sites in India 

Education details: M.Sc, B.Sc, M.Pharm, B.Pharm

Experience: 8 to 15 years

Location: Mumbai/ Gujarat

Kindly forward your profile to vignesh.iyer@sunpharma.com