CSV Validation Engineer - Ticino, Switzerland - Italian Speaker

CSV VALIDATION ENGINEER - VALIDATION - QA - GXP - GAMP5 - ISO 13485 - ISO 62304 - FDA QSR - 21 CFRPART 820 - PART 11

For one of our clients in the Pharmaceutical Industry we are looking for a VALIDATION ENGINEER.

Overall Responsibilities:

Working as PQS (CSV Validation Engineer) for the validation of Legacy software and software validation of production equipment. Creation of all needed documents to get the system complaint with the regulations.

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 executor required.
Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11.

Language Skills:

- Italian & English fluent, German is a plus

If you're looking for a new assignment in Ticino and you speak fluent Italian please send your updated CV in Word format