Job Reference: J5631534
Updated On: 07/08/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Computer Systems Validation (CSV) Contractor to join a pharmaceutical company based in the South West area. As the CSV Contractor you will be responsible for a number of projects requiring validation work in a GMP environment.
Key Duties and ResponsibilitiesYour duties as the CSV Contractor will be varied however the key duties and responsibilities are as follows:
1. As the CSV Contractor, you will be responsible for validating various computer systems which will include a variety of ERP based systems and Laboratory systems within a GMP environment.
2. Your role as the CSV Contractor 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 regulatory guidelines.
3. You will have significant experience across CSV within the pharmaceutical industry. This will be across both Laboratory and ERP systems.
4. You 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.
Role RequirementsTo be successful in your application to this exciting opportunity as the CSV Contractor we are looking to identify the following on your profile and past history:
1. Relevant degree in a Scientific or Technical discipline.
2. Proven industry experience in a CSV role within the pharmaceutical industry.
3. A working knowledge and practical experience with CSV for laboratory and ERP systems as well as required compliance within the pharmaceutical industry.
Key Words: CSV / Computer Systems Validation / Laboratory Systems / ERP / SAP / QC Systems / Validation / Computer Validation / Pharmaceutical / GAMP5 / GMP / Annex 11 / FDA / MHRA / Contract / Consultant
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