[Apply Now] DGM Corporate Quality

- Responsible for overall quality oversight functions of contract manufacturing organizations responsible for manufacturing of site transfer products (Sun site RD) for Domestic market.

Essential JobFunctions:

- Caused based frequent visits of the CMO sites for review of process practices.
- Coordinate with Sun site, commercial, corporate quality audit the CMO site as SPOC for activities related to product manufacturing and release and other technical issues.
- To review approve quality agreements between Sun Pharma CMO site. Also, ensure qualified and approved external service providers are used.
- To participate in new product launch evaluation and technologytransfer.
- To monitor ensure timely closure of market complaints, quality alerts, recallsetc.
- Review and approval of process validation, analytical validation, hold time study, stability study protocols reports.
- Tracking of open CAPA s and ensure effectiveness ofCAPA s.
- Review approval of annual riskassessments.
- To monitor evaluate productremediation.
- Tracking implementation of new projects as CMOsites.
- Review and approve SOP s as per Sun Pharma qualitystandards.
- Ensure timely implementation of Pharmacopoieal changes compliance.
- To ensure timely release of batches in SAPsystem.

Requirements andQualifications:

BasicQualification:

- M.Sc./ B. Pharm / M. Pharm orequivalent.

Industrial Experience Knowledge:

- Total 22-25 years of experience in Production, Quality Assurance, Quality and compliance in sterile formulations manufacturing.
- Knowledge of GMP s in both domestic and international regulatory environments. In-depth

knowledge of FDA guidance s such as ICH ismust.

- Strong organizational, interpersonal and communicationskills.
- Ability to work effectively in multicultural matrixorganization. Read more