Description
Manager, Computer System ValidationStart date: Latest 1st August
Length of assignment: planned for 1 year
Department: Pharmaceutical/Health Care
Geographic location: Switzerland
Our client, a major Pharma global player is currently looking for a CSV Specialist for a 12 months contract in Basel.
Major Activities
The CSV specialist will have overall responsibility for the management and approval of computer system validation processes and documentation, performing validation of computer and/or automation systems in compliance with current Good Manufacturing Practices (cGMPs) and all other relevant pharmaceutical regulations, guidelines and practices.
- Develop standard template to ensure effective and efficient CSV
- Assist in maintaining equipment automation systems in a validated state as they relate to GxP CSV automation systems
- Execute QA reviews and approvals of IT SOPs, and validate master plans for computerized system implementations
- Execute QA reviews and approvals of all validation related documentation (IQ, OQ, PQ, User Requirements, Plan and Traceability Matrix)
- Develop validation strategies, execute validation strategies & author validation documentation
- Develop an appropriate document control capability and ensure all documents filings and archiving
systems are accurate, up to date and maintained in accordance with GMP and other relevant regulations
Your Profile
- Bachelor degree in Computer Science or related field
- 6- 10 years quality system experience
- 3 to 5 years proven track record in Computer System Validation in pharmaceutical environment - Familiar with GxP systems
- Excellent analytical and problem solving skills
- Experience in 21 CFR Part 11, GAMP
- Excellent analytical and problem solving skills
- Willing to work in an international environment
Languages: Good knowledge in English (oral and written) required; fluent in (German) desirable If this outstanding opportunity sounds interesting to you, do not hesitate to contact me for more details or send me your CV. For more information on this or other opportunities, please contact Sabina Keel at Real Staffing on or
Keywords: CSV, CSV Specialist, Computer System Validation, QA, Validation, Pharma, Switzerland,