Description
On behalf of my client, a well-known life sciences company, we are currently seeking a CSV consultant for a 6 month project in central Switzerland.Task:
- Execute several Software Validation projects in accordance with corporate IT/Quality and industry standards (ISO 13485, 21 CFR 820, 21 CFR 11, GAMP 5)
- Write validation plan, URS, FS, risk assessment
- Write IQ/OQ/PQ protocols, reports, VSR. Execute testing in collaboration with local validation team
Requirements:
- Minimum 3 years of experience of Computer Systems Validation (GAMP5) within the Pharmaceutical / Medical Device / Life Sciences industry
- Expertise in US FDA (esp. 21 CFR Part 11) and UK MHRA Regulations, ISO Standards and GAMP5 Principles
- EQMS or Document Management
- German and English fluent both written and spoken
- Team player
- Strong customer orientated mind set
Details:
- Office based in central Switzerland
- Ideal start is Q4 2016
- Level of experience should be Junior/ Professional
- 40hr weekly
If you are interested or you know someone who fix in this role please feel free to contact me, to discuss this role in further detail.
Keywords: CSV, Computer validation, FDA, GAMP 5, german, english, pharma, medical devices