CSV Business Analyst - CSV - 120 CHF per hour - Basel Area - German Sp

CSV BUSINESS ANALYST - CSV - 120 CHF PER HOUR - BASEL AREA - GERMAN SPEAKING

KEY SKILLS - Computer system validation, CSV, Business Analyst, Medical device, ISO 13485, Computer validation, Computer System Compliance, CSC, GXP, GMP, System Testing, UAT, User acceptance Testing, 

My client is one of the world best known medical device companies based in Switzerland.  Due to the sign off on a large IT infrastructure project we are currently sourcing 7 Business Analysts with a background in Computer system validation.

Your 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. 
- Knowledge in technical skills like Technical Writing is requested 

Experience & Education Requirements:

- Higher education (Engineer or similar) and background in Computer System Validation and at least 5 years work experience 
- Responsibility in similar management position or extended experience as executer required. Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, Part 11 
- Familiarity with med. device manufacturing plants
- Team Player, able to work in a flexible environment with diverse characters/instances with excellent communication and co-operation skills. 
- Minimal language skills: 
- English fluent
- German fluent