Manager/ Senior Manager - Central Quality - IV - API

Sr. No. Job Responsibilities 1. Facilitate monitoring of compliance to QMS norms and preparation of monthly quality reports of sites. 2. Support for regulatory, SME audit and Facilitate for preparation of audit response and review of response. 3. Support for failure and repeated failure investigation to site. 4. Review of global CAPA, regulatory commitments, its implementation and effectiveness at API sites. 5. Overview of Quality Management System documents at API sites for ensuring its adequacy and completeness. § Change control § Deviation § Out of specification and Out of trend § Market complaint, Return and Recall § Annual Product Quality Review (APQR) 6. Overview of API site validation and qualification documents for ensuring its adequacy and completeness i.e. § Process validation § Cleaning validation § Equipment Qualification and § Utilities qualification (N2, Air, Water and HVAC) 7. Review of periodic trends report of utility (N2, Air, Water and HVAC, Breakdown) for ensuring its adequacy and completeness. 8. Support for vendor qualification and vendor audit of KSM/API and its traceability with respect to compliance to vendor audit cell. 9. CQ policy and directive preparation, review and its implementation at sites. 10. Periodic auditing of online documentation to identify and address recurring issues. 11. Review of site compliance report as applicable and follow ups for adequate closure through appropriate supporting documents and addendum reports from site. 12. Identify specific areas of improvement based on the emerging trend. 13. Review of other QMS reports by site based on the requirements i.e. consolidated reports, assessment summary etc.