Beschreibung
CSV Validation Engineer
Edelway AG is a Professional Services Consultancy based in Switzerland. One of our best clients, a global pharmaceutical company is currently looking for a CSV Validation Engineer to join them on a long term basis (contract or permanent).
Language: English and (German or Italian).
Start Date: ASAP
Rate: Excellent
Location: Mezzovico, Solothurn or Basel/Bern.
The Role:
*Working as PQS (Pharmaceutical Quality System) for the validation of Legacy and software validation of production equipment.
*Creation of all needed documents to get the system complaint with the regulations.
*Know and follow the guidelines regarding the code of conduct, ethics and compliance programs.
*Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).
Your Profile:
*Fluent English and (German or Italian-for Basel/Bern or Mezzovico respectively)
*Higher education in Engineering or related fields.
*Min 5 years work experience.
*Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11.
*Excellent customer service, interpersonal, communication and team collaboration skills.
If this sounds like your next challenge send us your CV and we will call you to discuss the role in more details.