Job Description

Medical

GMP Validation Officer

Location:
Morpeth
Salary:

Job Requirements/Description
GxP Recruitment invites applications on behalf of their biopharmaceutical client in Northumberland where an excellent opportunity has now arisen for an experienced Validation Officer to join their team on a permanent or contract basis. Key duties include: * Specific focus on CSV * managing validation documentation * ongoing validation and qualification activities of existing systems and processes * liaising closely with Quality to ensure equipment and facility files are maintained; * managing software packages for Asset Management, Maintenance Schedules, and PPM * preparing, reviewing, and maintaining documentation to appropriate quality standards, including, but not limited to SOP’S Study Protocols, validation plans, validation reports, COSHH assessments, Risk Assessments, URS, DQ, IQ, OQ and PQ protocols * assisting line managers in the preparation of change controls, implementing changes and raising deviations where appropriate for any change which may have an impact on the facility meeting regulatory standards; * providing assistance with any technical engineering activities required during external / internal audits The ideal candidate profile: * Previous experience in a validation role * Experience of Computer System Validation * Engineering or Science degree with validation experience within a GMP regulated environment * Communicate effectively both verbally and written * Experience in using Word and Excel spreadsheets
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