Computer Systems Vaildation Consltant

Basel  ‐ Vor Ort
Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
Sie finden vakante Projekte hier in unserer Projektbörse.

Beschreibung

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&V methodologies, and software configuration management.
- Demonstrated understanding of FDA Quality System Regulation and ISO/EU standards pertaining to computer software validation (eg, 21CFR Part 820, subpart G Production and Process Controls, 820.70 (i) software validation/automated processes; 21 CFR Part 11 Electronic Records & Signatures; ISO 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.

Start
16/07/2018
Dauer
2 months
Von
Square One Resources
Eingestellt
10.07.2018
Projekt-ID:
1595369
Vertragsart
Freiberuflich
Um sich auf dieses Projekt zu bewerben müssen Sie sich einloggen.
Registrieren