Beschreibung
Validation Expert - Computer System Validation/GxP
About us:ITech Consult AG is a certified ISO Swiss company with offices also located in Germany, Great Britain and Ireland. ITech Consult is specialised in delivering ICT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.
Reference No.: 916615NC
Role: Validation Expert - Computer System Validation/GxP
Industry: Pharmaceutical
Location: Basel und Region; Switzerland
Work load: 100%
Start Date: ASAP
Duration: Till 31.12.2017 (Possible Extension, but not approved yet)
Required Skill:
-Minimum 5 years Proven track record in Computer System Validation in pharmaceutical environment.
-Strong project management skills with the ability to prioritize assignments
-Lead responsibility working with all system owners to ensure company systems continue to conform to MHRA & FDA requirements for Data Integrity within computer based systems
-Familiar with GxP systems.
-Excellent analytical and problem solving skills.
-Willing to work in an international environment.
Tasks & Responsibilities:
-Review and approve deliverables related to CSV in a GMP laboratory environment
-Execute QA reviews and approvals of IT SOPs
-Execute QA reviews and approvals of user and functional requirements for new and existing computer systems
-Execute QA reviews and approvals of all validation related documentation (IQ, OQ, PQ, User Requirements, Plan and Traceability Matrix).
-Establish and ensure good and close working relationship with important project stakeholders and internal customers.
Education:Master in engineering, IT, science, or computer related discipline or Similar
Languages:
-Fluent in English
-Fluent in German is an advantage
Should you find yourself suitable for this position then send your complete dossier using this link in the advert.
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