Business Analyst

For a contract with our client in Solothurn we are looking ASAP for a

Business Analyst (IT and Computer System Compliance)

Key Requirements:

- 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

Key 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 CFRPart 820, Part 11Familiarity with medical device manufacturing plants, SDLC (prefer J&J but can be flex).
- Minimal language skills: English & German both fluent

Are you interested in this position? Then we are looking forward to receiving your application.