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 current 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 deliverables The 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.

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