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
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