Job Reference: J5631990
Updated On: 01/11/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a IT CSV Technician to join a leading Life Sciences company with offices across the UK. As the IT CSV Engineer you will be responsible for supporting the CSV Manager with validation duties within a GxP, GLP, GMP environment.
Key Duties and ResponsibilitiesYour duties as the IT CSV Engineer will be varied however the key duties and responsibilities are as follows:
1. Assisting the validation of computerised systems in a GxP environment and the preparation of CSV documentation including Risk Assessments, Validation Plans, User Requirements Specifications, Qualification Test Protocols, Test Scripts, and Validation Reports.
2. Monitor CSV activities within own area of accountability, to ensure quality and compliance with all legislation, regulations and standards.
3. Provide CSV expertise and risk analysis in order to agree the validation approach, if any, for projects and change control requests
4. Use the procedures, tools and techniques for undertaking CSV as directed by the CSV Analyst to monitor the alignment of CSV activities with all relevant legislation, regulations and standards.
Role RequirementsTo be successful in your application to this exciting opportunity as the IT CSV Engineer we are looking to identify the following on your profile and past history:
1. Relevant degree in Computer Sciences or an equivalent Life Sciences subject
2. Proven industry experience in computer systems validation equivalent to 2 years
3.Working knowledge of systems such as Laboratory Systems, Document Management Systems Proficiency in both verbal and written communications and possess a high degree of personal integrity and interpersonal skills.
Key Words: CSV, Validation, Computer Systems, LIMS, Quality, ERP
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