CSV Analyst

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.



KEY DUTIES AND RESPONSIBILITIES:

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

ROLE REQUIREMENTS:

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.