Beschreibung
A growing Medical Technology company specialised in the manufacture of Class IIb and Class II products is looking for an Independent CSV Expert consultant to work on upgrading and working on current systems.Job Overview
- Looking at a risk based validation strategy for all QMS
- Procedures and SOPs need to be written and established
- Documentation Validation
- There are legacy Computer systems that need assessing against compliance
- Knowledge transfer required to the wider team
- Looking into new ERP systems / Customer Relationship products
Key Skills + Requirements
- 5+ years' + experience in CSV in the Life Science Industry ( Medical Device / Pharma / Biotech backgrounds okay)
- Experience on working with Gamp 5 & 21 CFR Part 11
- Fluent in German and English
The project is starting between January and February -
After an initial 2 weeks full time site based the role will have 2 days of home based flexibility.
The project will run until July with possibility of extension.