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CSV Validation Specialist

Job LocationNorthumberland
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Leading Pharmaceutical Development and Manufacturing Company based in Northumberland seeks an experienced CSV Validation Specialist.About the role:The Validation Officer, Computerised System Validation (CSV) has responsibility for the management and execution of validation activities, with a significant focus on computerised systems.The role requires excellent coordination with clear and adaptable communication with external and internal stakeholders, such as Vendors, Customers, Quality, Project Management, Operations and Purchasing.Skills and experience:

  • Experience in the pharmaceutical industry in a similar role (Quality IS/IT, QA, CSV, etc.)
  • Excellent knowledge of GMP, including the MHRAs Orange Guide, EUs Eudralex Vol. 4, USAs CFRs, ISO, ICH, GAMP and PIC/S.
  • Strong validation knowledge, particularly around computerised systems
  • The requirements of the qualification life cycle within pharma, following on from commissioning through to de-commissioning
  • A University Degree is preferred for this role, but not essential (experience dependent)
INDHP

Keyskills :
GMPPharmaceuticalValidationCSV

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