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Sun Pharma is the Fastest Growing Pharmaceutical company in the world with 2000 Products, above 30,000 workforce Presence in Over 100 Countries and Manufacturing Facilities in 40 Countries.
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Sun Pharma recognizes its employee’s passion for growth and empowers them to achieve their aspirations. We owe our success to our passionate and skilled workforce. At Sun, one can work with an inspiring, approachable, and visionary leadership. Our open, enabling and trust-based culture will offer you an exciting environment to work and excel in your chosen career.
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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