Beschreibung
Business Analyst, Computer System Validation Engineer mit FDA Erfahrungen gesucht.Computer System Validation:
? 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 at least 4 years work experience
Familiarity with med. device manufacturing plants, SDLC (prefer J&J but can be flex).
Team Player, able to work in a flexible environment with diverse characters/instances with excellent communication and cooperation skills.
Minimal language skills:
English & German fluent