Quality Assurance Manager

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site.

Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc.

Coordination for Handling market complaints / Returns/Deviations / OOS.

Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site.

Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site

Organization of regulatory and customer Audits

Organization of Meeting / Seminar / Presentation / trainings/ Management Review Meeting (MRM) etc. internally to achieve QMS

Coordination for Technology Transfer Document (TTD) review and new product initiation.

Reviewing and approving validation protocols and reports

Approving intermediate and API contract manufacturers

Ensuring that all Quality related complaints are responded as per SOP

Review and Coordination for Batch Processing and packing record.

Review of Quality Manual / VMP / SMF.

Preparation and review of external audit responses then proposed CAPA monitoring.

Maintaining Updated documents as per standard of ISO 9001:14001. Maintaining documents as per USFDA, CGMP, and other regulatory guidelines requirements.

Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place

Ensure all the activities / documentation as per the cGMP guideline

Any other activities assigned by reporting manager.