Computer System Validation Analyst

Hiring By - Biostaffic


United Kingdom

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details

We are currently looking for a CSV Analyst to join a leading European specialist pharmaceutical company based in Wales. As the CSV Analyst you will be responsible for ensuring that IT Quality Management System, Validation documentation and all related processes, procedures and systems meet the requirements of all applicable regulations.


Your duties as the CSV Analyst will be varied however the key duties and responsibilities are as follows:

Assist the CSV/Lead Process Analyst in continued improvement and delivery of the Global IT 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

Support the continuous improvement of appropriate procedures to be used in validating computerised systems.

Support project teams in the assessment of proposed new computerized systems or software for GxP impact and where GxP impact is identified provide guidance on the risk based validation approach for the system, working with key stakeholders to achieve business goals.

Acts as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Risk Management


To be successful in your application to this exciting opportunity as the CSV Analyst we are looking to identify the following on your profile and past history:

1. Wide experience of the various regulatory requirements relating to Eudralex Annexe 11, FDA CFR21 Part 11, etc..

2. Substantial experience in a validation and qualification of complex computer systems

3. Familiarity with multiple system types such as ERP and BI, LIMS, HRIS etc

Key Words: CSV, Computer System Validation, GxP, IT Quality Management System, ERP, LIMS

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No


  • United Kingdom


  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview
Hyper Recruitment Solutions
Hyper Recruitment Solutions

Current Openings: 0

Hyper Recruitment Solutions (HRS) is an award-winning specialist, and highly compliant, recruitment consultancy dedicated to the Science and Technology sectors. Based in Essex, London, Manchester and Edinburgh with additional European offices coming soon. Founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff on both a contingency and retained search basis. Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place with the aim to help companies to create life-saving medicines, and life changing technologies. Our network extends across the global and we support a number of specialist sectors which are in line with our vision. • Biotechnology • Pharmaceutical • Medical Device • Life Sciences (including Cell and Gene Therapy) • Clinical Research • Food / FMCG From a candidate perspective we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises.
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