Associate QA – EPD Quality Systems for MNC Pharma Company

Primary Job Function:

·      This position is responsible for managing Quality Systems programs and initiatives within the EPD Quality System organization to ensure safe, effective and quality products can be supplied in accordance with regulatory and business requirements.

·        This position is responsible for managing audit processes in SolTRAQ related to Affiliates, Suppliers and Third-Party Manufacturers.

Core Job Responsibilities:

·        Act as a Subject Matter Expert for assigned Quality Systems.

·        Maintain an excellent understanding of actual and future regulatory expectations for EPD products and provide support for transition into the Business Unit as required.

·        Leads global initiatives and works with the Business Units to coordinate activities and ensure implementation.

·        Participate on QA cross-functional teams as necessary.

·        Responsible for preparation and review of the QMS documents.

·        Support Auditing team by performing GMP Auditor role activities including tracking of Open audit records in SolTRAQ.

·        Support for audit documentation management in AudiQ module.

·        Support quality and compliance initiatives.

·        Monitoring KPIs and maintain Audit management Dashboard