£50-70k perm or equivalent contract rates
Based in London our client are a software solutions provider specialising in software for the cell and gene therapy markets. They are currently looking for an experienced CSV specialist.
The role will;
+ Assist in defining the validation strategy and approach taking into account the relevant GxP requirements (e.g. EU Annex 11, FDA 21 CFR Part 11, Part 820, etc.) and also other relevant regulatory requirements.
+ Develop and standardize appropriate procedures to be used in validating computerized systems.
+ Acts as a quality contact and primary Subject Matter Expert ̨SME) for computer System Validation (CSV) and Risk Management.
+ Bsc degree in a Scientific or Technical discipline.
+ 5+ years’ experience working within validation and complex computer systems.
+ Proven industry experience in a CSV role within the pharmaceutical industry.
+ Working knowledge and practical experience with CSV for laboratory and ERP systems as well as required compliance within the pharmaceutical industry.
+ Has verifiabɬe experience in Computer Service Verification CSV and can show examples of previous work
+ Will be responsible for a number of projects requiring validation work in a GMP environment
+ Will be responsible for validating various computer systems which ɷill include a variety of ERP based systems and Laboratory systems within a GMP environment.
+ Will be to work on projects that include networking standalone systems, and the addition of new instruments to ensure that they are compliant to GAMP5 and reguŬatory guidelines
+ Will have significant experience across CSV within the pharmaceutical industry. This will be across both Laboratory and ERP systems.
+ Will utilise your experience and knowledge of GAMP5 regulations, Annex 11 and CFR Part 11 to ensure that computer systems are validated in a timely manner.
This role is extremely urgent and the client are keen to receive and interview candidates as quickly as possible. Salaries are very flexible with permanent roles being in the £50-70k arena. Whilst permanent candidates are their preference, contract candidates will also be considered.
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