Sun Pharma is looking for Pharma and Chemistry candidates for the following post of Manager – CMO – QA. The job details are given here.
From humble beginnings in 1983, Sun Pharma has grown to become the 5th largest generic pharmaceutical company in the world and No. 1 in India. Our passion for research has enabled us to develop over 2000 products that are sold in more than 100 countries worldwide. Our global presence is supported by over 40 manufacturing facilities spread across six continents and R&D centers across the globe.
Innovation is at the core of the Sun. We have nearly 2000 scientists working in six research centers across India, Israel, and USA who have a passion for innovation and longing to provide better healthcare to humanity at large. Our multi-cultural workforce, comprising over 30,000 employees from 50 nationalities, is our biggest strength.
We recognize our employees passion for growth and empower 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.
Job Title: Manager – CMO – QA
Qualification: M.Sc, B.Sc, M.Pharm, B.Pharm
Experience: 8 to 15 years
Job Location: Mumbai/ Gujarat
Salary: Not Disclosed
Skills: QA, Validation, LIMS, OOT, OOS, CAPA, Contract Manufacturing Sites, Quality Management, Technology Transfer
- 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 are 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.
- Thorough investigation of complaints with RCA and appropriate CAPA.
- Participate in the Investigation of critical and repetitive complaints along with the 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