Beschreibung
Subject Matter Expert: Packaging, sterile, non sterile, GMP, ISO 13485, German, Medical Device
I am looking for a self motivated professional with an excellent eye for detail for a position with the worlds largest life-science organisation. You will be able to speak fluent English and German for this position and ideally have a couple years experience within the pharmaceutical or medical device industries and have a good understanding of GMP guidelines.
Job description:
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 and regulated industry preferred
- Prior experience in medical device/pharmaceutical remediation preferred
- Background on validation procedures and packaging technology helpful
- Proficient in the use of spreadsheet software (Access/Excel etc.)
- Thorough understanding of GMP guidelines
Subject Matter Expert: Packaging, sterile, non sterile, GMP, ISO 13485, German, Medical Device