Job Reference: J5635011
Updated On: 26/05/2021
Status: Open to Applications
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Role OverviewWe are currently looking for a CSV Specialist to join a leading Pharmaceutical company based in the South East of the UK. As the CSV Specialist you will be responsible for acting as a Data Integrity lead, executing remediation activities in line with project requirements. Please note this role has been assessed Outside IR35 and a 12 month contract initially.
Key Duties and ResponsibilitiesYour duties as the CSV Specialist (12 month) will be varied however the key duties and responsibilities are as follows:
1. Liaise with the validation team, end users and senior project staff to ensure Remediation project is delivered on time.
2. The CSV Specialist will ensure laboratory instrumentation is validated in accordance to GMP Annex 11, CFR21 Part 11 and cGMP.
3. Act as a Data Integrity lead, executing remediation activities in line with identified data integrity gaps.
Role RequirementsTo be successful in your application to this exciting opportunity as the CSV Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Pharmaceutical/IT related discipline.
2. Proven industry experience in CSV, Data Integration and Remediation.
3. A working knowledge and practical experience with laboratory instrumentation.
Key Words: CSV / Computer Systems Validation / Data Integrity / Remediation / cGMP / Laboratory / LIMS / Instrumentation / Outside IR35 / Contract / Validation
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