Beschreibung
CSV Consultant
Edelway SA is a Swiss IT Services Consultancy. Our global multinational end-client based in the Basel/Bern area is currently looking to hire a CSV Consultant on a long-term basis.
Working language: English and German
Full time engagement at least until end of 2014.
Starting Date: ASAP
THE ROLE:
- Work with IT and Computer System Compliance (CSC) partners on remediating computer systems at manufacturing plants
- Work with and support the Business Owners with the business deliverables for Computer Systems
Validation of GXP including not limited to:
* Requirements Identification and documentation
* System Test Scripting
* System Test Execution
* UAT Test Scripting
* Writing of Work Instructions/Procedures
- Work with IT and CSC in planning of validations of GXP systems.
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- Knowledge in technical skills like Technical Writing is requested
YOUR PROFILE:
*background in Computer System Validation and at least 5 years work experience
*Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
*Familiarity with med. device manufacturing plants, SDLC
*English & German fluent
If it sounds like your next challenge, send your CV and we will contact you shortly to discuss it further
Keywords: CSV, Pharma, Basel, Medical Device, Testing, User Acceptance Testing, Basel, Bern, Computer System Validation, Schweiz, Switzerland