Beschreibung
CSV (Computer System Validation) with GxP (GAMP) Life Sciences Senior Consultant required for approximately 10 days consulting work over a 3 month period to help our client develop a procedure for validation within one of their Managed Services projects.
Requirements:
Completed studies in a relevant field (life sciences, process engineering, chemistry or business informatics, etc.)
Very good knowledge and at least 4 years professional experience in quality management and/or validation of IT systems in the pharmaceutical or medical device manufacturing industries
Knowledge acquired in practice in the application of GAMP 5, 21 CFR Part , EU GMP Guideline Annex 11/15, etc.
Experience in building and implementing IT quality management systems in the pharmaceutical and/or medical technology field desirable
Excellent presentation and communication skills in German and English
Willingness to travel nationally and work locally at the customer