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, F

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