Job description
- Responsible for overall quality oversight functions of contract manufacturing organizations responsible for manufacturing of site transfer products (Sun site & R&D) for Domestic market.
Essential Job Functions:
- 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 technology transfer.
- To monitor & ensure timely closure of market complaints, quality alerts, recalls etc.
- Review and approval of process validation, analytical validation, hold time study, stability study protocols & reports.
- Tracking of open CAPA s and ensure effectiveness of CAPA s.
- Review & approval of annual risk assessments.
- To monitor & evaluate product remediation.
- Tracking & implementation of new projects as CMO sites.
- Review and approve SOP s as per Sun Pharma quality standards.
- Ensure timely implementation of Pharmacopoieal changes & compliance.
- To ensure timely release of batches in SAP system.
Requirements and Qualifications:
Basic Qualification:
- M.Sc./ B. Pharm / M. Pharm or equivalent.
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 is must.
- Strong organizational, interpersonal and communication skills.
- Ability to work effectively in multicultural matrix organization.
