Beschreibung
CSV Validation Engineer - German - ERP - QA - PQS - Validation - GxP - GAMP5 - ISO 13485 - ISO 62304 - FDA QSR - 21 CFRPart 820 - Part 11
CSV Validation Engineer
For one of our clients in the pharmaceutical industry we are looking for a CSV Validation Engineer.
Main tasks:
- Support and consulting during projects handling GxP critical computer systems
- Creation of the Validation documentation for GxP relevant systems
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
Extended Duties:
- Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).
Required skills:
- Higher education (Engineer or similar) and background in IT and at least 5 years work experience
- Responsibility in similar 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
Language Skills:
- German & English fluent
If you're looking for a new assignment and your profile matches the requirement please send your updated CV in Word format