Quality Assurance Manager

4 weeks ago

Hyderabad India Promea Therapeutics Full time

Job Description Job Responsibilities - To ensure Sit Ready for anytime Regulatory Inspection in Compliance to cGMP Norms of Various Regulatory Bodies. - To train personnel on cGMP, regulatory expectations, and quality systems to enhance compliance and awareness. - To ensure Vendor Qualification activities are conducted as per SOPs, and maintain an up-to-date Approved Vendor List and requalification of Vendor Schedule. - To ensure Quality Assurance, Quality Control, Microbiology, Production, Warehouse, Engineering activities are performed in compliance as per current GMP requirement and their effective implementation. - Responsible for ensuring QMS elements (Change Control, Deviations, CAPA, OOS, OOT, etc.) are implemented and managed as per defined procedures. - To conduct Management Review Meetings and ensure follow-up on key quality metrics and action items. - To Represent the organization during customer audits and regulatory inspections; ensure timely responses and effective implementation of Corrective and Preventive Actions (CAPAS). - To Approve SOPs, Level-1 documents, and quality-critical documentation. - To ensure all critical and major changes (process, facility, or system) are executed based on risk assessment and maintain validated status post-implementation. - Authorized the Batches release in the Market. - To provide guidance to QA and cross functional departments for compliance to various international cGMP requirements. To co-ordinate with cross-functional HOD's to implement cGMP in Plant.

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