Beschreibung
Computer System Validation (CSV) Business Analyst - Switzerland
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
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 11
Familiarity with medical device manufacturing plants, SDLC