Computer Systems Vaildation Consltant

Computer Systems Validation Consultant
Switzerland - Basel
2 months initially
£765 per day

Computer Systems Validation Consultant required with experience of working with CSV and software application validation. The role is based in Basel and will be initially for 2 months.

Key Responsibilities/duties
- Strong experience in Software application validation.
- Identify gaps in current design documentation and support the state of the installed control system
- Developing various test specifications which includes functional testing, system integration testing, performance testing and compliance testing
- Grow and maintain solid client relationships.

Key skills required
- Strong knowledge in the CSV regulations (EU: annex 11 and FDA: 21CFR part11)
- Experience in an FDA regulated environment with strong knowledge of regulatory compliance pertaining to software validation in IT Infrastructure and Enterprise Systems supporting business, or quality management (eg, Agile, SAP, MES) plus in-house developed software applications.
- Experience within a dedicated a CSV or product software validation role. Proficient in system and software validation engineering processes, software risk management, software V 21 CFR Part 11 Electronic RecordsISO 13485.

Desirable/Beneficial skills
- Background in the life sciences and/or Pharma/Biotech/Medtech industries
- Understanding of GAMP5 and risk-based approach to validation is required

If you are interested in this opportunity, please apply now with your updated CV in word/PDF format.

Notwithstanding any guidelines given to level of experience sought, we will consider candidates from outside this range if they can demonstrate the necessary competencies.

Square One is acting as both an employment agency and an employment business, and is an equal opportunities recruitment business. Square One embraces diversity and will treat everyone equally: Please see our website for our full diversity statement.