Swiss Responsible Person and GDP Quality Assurance role at Rhythm, a global biopharmaceutical company. The RP will be responsible for product quality and regulatory compliance in Switzerland and provide overall support to the global GDP operations.
Requirements
- Maintain an effective QMS, overseeing authorized activities and ensuring accurate, high-quality records.
- Ensure non-conforming medicinal products are clearly labelled and not released to the market, and that packaging complies with current Swissmedic approvals.
- Effectively manage product quality complaints and temperature excursions.
- Conduct regular self-inspections according to a set schedule, monitor GDP compliance, and implement corrective actions as needed.
- Approve test reports for finished medicinal products or returning saleable products.
- Ensure appropriate samples are taken and kept as retention samples.
- Complete all mock or actual recalls accurately and within the specified time frame.
- Supplying medicinal products in Switzerland only to customers authorised to distribute them under GDP.
- Ensure suppliers and subcontracted activities are approved and qualified.
- Ensure that initial and continuous training programs are implemented and maintained.
- Act as contact person for Swissmedic.
- Ensure Swiss-specific assessment and evaluation of APQRs are conducted in accordance with Swissmedic timelines.
- Conduct Annual Management Reviews.
- Manage deviations and changes appropriately, and promptly notify Swissmedic of any major change according to Art. 41 of MPLO.
- Ensure that appropriate Corrective and Preventive Actions (CAPAs) are clearly defined as required and effectively managed throughout their implementation.
- Ensuring potential risks are thoroughly analyzed and managed effectively.
- Support global GDP operations by reviewing documents, preparing batch disposition and returns paperwork, and coordinating approval processes within Veeva.
- Manage temperature excursions and distribution events ensuring all incidents are properly recorded and corrective actions are implemented in line with global GDP standards.
- Support GDP audits and self-inspections, including management of records within Veeva eQMS.
- Support maintenance of global GDP procedures, work instructions, forms, and templates to ensure consistent execution across all Rhythm GDP markets.
- Contribute to global GDP change control, deviation, CAPA, and quality event administration, ensuring consistent documentation and follow-up across regions.
- Coordinate global GDP training activities.
Benefits
- Competitive salary
- Benefits package
- Opportunities for professional growth and development
