Analyst - Policy and Projects - Wales, United Kingdom - Hyper Recruitment Solutions Ltd

Description

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.

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. and also other relevant regulatory requirements

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
Wide experience of the various regulatory requirements relating to Eudralex Annexe 11, FDA CFR21 Part 11, etc.
Substantial experience in a validation and qualification of complex computer systems
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 Interested in this job? We look forward to helping you with your next career moves.

Pharmaceutical, Software, IS&T
com HRS Registered Office
Bounds Building, 68 Sackville Street