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Designation: Manager Contract Manufacturing – QA

Location: Mumbai, Maharashtra

Job Description:

  • Responsible for review of batch related documents and release of Loan Licence products (Contract Manufacturing sites).
  • Preparation & review of specs and steps 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 the 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.
  • A thorough investigation of complaints with RCA and appropriate CAPA.
  • Participate in the Investigation of critical and repetitive complaints along with site quality team.
  • Monitor implementation of CAPA as per the 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

Qualification: B.Sc/M.Sc, B.Pharma/M.Pharma

Experience: 9-14 Years

Salary: Negotiable

Contact Details:

vignesh.iyer@sunpharma.com

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