Compliance: QA, GMP, Packaging, Validation, Medical, SAP, Data

Compliance: QA, GMP, Packaging, Validation, Medical, SAP, Data

A multinational company is seeking a subject matter expert to join their team in Solothurn, Switzerland. This is a fantastic opportunity for a professional looking to broaden their experience within a world renowned company. The subject matter expert must be; highly organised with a great eye for detail, be a good team player, and must hold the ability to manage multiple priorities and tasks effectively. Communication is important within any business, which is why fluent German coupled with spoken and written English is an advantage.

Responsibilities:

- Ensure availability and correctness of packaging documentation for sterile and non sterile medical devices, in compliance with all valid regulations (ISO, FDA, etc.)
- Check packaging configurations (Bill of material) and packaging validation documentation (package transit qualification, packaging shelf life) in PLM/ERP systems and verify their correctness
- Perform updates/changes (DCR/DCO) for non conforming packaging documents and Bill of Materials in the systems (Agile/SAP)

Experience:

- 2 years work experience in an adequate position, regulated industry preferred
- Prior experience in medical device/pharmaceutical re-mediation preferred
- Background on validation procedures and packaging technology helpful
- Proficient in the use of spreadsheet software (Access/Excel etc.)
- Thorough understanding of GMP guidelines