RA/QA Operations Specialist
Zentiva Poland
- Indiana, Pennsylvania, United States
- Indiana, Pennsylvania, United States
À propos
India Apptime type:
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R2469298**MISSION STATEMENT**Main Job Purpose:The RA/QA Operations Specialist supports the Responsible Person (FvP) in ensuring full compliance with Swissmedic, GMP and GDP requirements for all regulated activities related to import, distribution, release and lifecycle management of medicinal products in Switzerland.The role combines operational Regulatory Affairs and Quality responsibilities, ensuring product quality, regulatory compliance and patient safety across the entire product lifecycle.**MAIN ACCOUNTABILITIES AND DUTIES****Quality system management*** Support implementation and maintenance of the local Quality Management System in line with Swissmedic, GMP and GDP requirements* Ensure compliance with internal procedures and regulatory standards for all GxP-relevant activities* Support inspection readiness and participate in internal audits and health authority inspections* Create, review and manage SOPs and quality documents in eDMS and support training implementation* Take ownership of assigned QA processes (e.g. deviations, complaints, CAPAs, change controls)* Manage product-related deviations, complaints, temperature excursions and quality events* Perform initial assessments, support root cause analysis and propose CAPAs* Coordinate cross-functional investigations with Supply Chain, RA and external partners* Ensure timely closure and effectiveness tracking of CAPAs* Act as Change Manager in Quality Forward for all changes under responsibility of the Swiss Affiliate* Initiate, coordinate and track Change Controls in alignment with regulatory requirements* Manage changes including labelling updates, MAH changes, packaging site changes and lifecycle variations* Support preparation and submission of regulatory variations for the Swiss portfolio* Prepare application forms and submission documentation in line with Swissmedic requirements* Draft and compile submission texts in German (official correspondence language)* Coordinate and prepare product information texts (SmPC, PIL) in German, French and Italian* Upload approved texts to AIPS in a compliant and timely manner* Coordinate regulatory activities for new registrations, including originator sample management* Organize procurement and shipment of samples (e.g. via wholesalers and logistics providers)* Create and manage mock-ups for new products and artwork updates* Review artworks for compliance and coordinate lifecycle activities (e.g. Vista tool)* Support local repack activities and release of packaging materials* Maintain and update regulatory databases and tracking tools* Manage RA-relevant tables and ensure data consistency* Initiate and track Purchase Requests (e.g. Fiori) for regulatory activities* Archive regulatory documentation in compliance with internal and regulatory requirements* Maintain transparency on project status, timelines and deliverablesThe employee will perform other tasks under the direction of the Manager within the agreed type of work.**OTHER RESPONSIBILITIES*** Leads small to mid‐size improvement projects (e.g. eDMS optimization, process harmonization, training programs).* • Represents the Quality, RA department in cross‐functional meetings for assigned products and processes. #J-18808-Ljbffr
Compétences linguistiques
- English
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