Description
Your tasks:You will be responsible to define the Quality IT validation strategy for the deployment and maintenance of Electronic Quality Systems for GMP/GDP related activities of Global Healthcare Operations. You will assure the 21CFR part 11 and EU GMP Annex 11 compliance of systems under your responsibility. You will lead cross-functional teams to define and improve the effectiveness and validity of the Biopharma GMP/GDP IT systems. You will be the key point of contact for Quality IT validation best practices. Your key interfaces will be Corporate Quality and Information Technologies (IT) in regards of Computerized System Validation (CSV). You will be the Process Owner of IT CSV documentation within the divisional Pharmaceutical Quality System (PQS).
Your qualification:
- Academic degree in applied sciences (Chemistry, Biotechnology, Pharmacy)
- Expert know-how in Computerized Systems Validation: Proven track record in qualification and validation of Electronic Systems Qualification (Validation) according to regulations (21 CRF part 11 and EU GMP Annex 11)
- Excellent knowledge of GMP/GDP
- Expert knowledge in validation of data lakes (complex IT networks, "big data analysis") and cloud-based computer systems
- Fluent in English, written and verbal. German language is a plus
- Excellent interpersonal, collaboration and communication skills
- Strong business mind-set with demonstrated ability of conceptual and strategic thinking
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.