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

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  [email protected]

Apply for this position

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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