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CSV Specialist Lead

Job LocationEly
EducationNot Mentioned
Salary50,000 - 70,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

CSV Specialist LeadLeading Chemical/biotechnology CRO requires a CSV Specialist based in the Cambridge area, on a full time, permanent basis. The company produces specialist analysis and services to healthcare and pharmaceutical sector.As part of the current expansion we require an expert for a Computer Systems Validation (CSV) specialist to join the Company. Reporting to the IT and CSV team this role will ensure all computerised systems used to support GMP, GLP and GCP programmes acrossthe sites and business.Duties may include the following:

  • Own full lifecycle validation for all applicable computerised systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance.
  • Leading on the CSV Validation of business systems and applications.
  • Working effectively with project teams to compile user requirements for local and group software systems.
  • Using quality risk management to deliver scalable approaches to CSV across the business for new and existing platforms.
  • Plan and execute qualification/validation (DQ, IQ, OQ, PQ,FATS, SATS)
  • Establish service level working across all functions and delivering site qualification plan
  • Subject matter expert for CSV Computer systems validation
  • Input and define User Requirement specifications
  • Responsible person for CSV sign off
Essential Skills / Qualifications:Essential, a degree in a software or engineering related discipline,Ideally a minimum of 5 years experience working with automated systems in a cGMP, GXP, GCP or GLP environment and up to data knowledge of industry regulationsExperience at executing validation, data management and data integrityAbout us: Templarfox if a privately owned recruitment business leading in executive search, management selection, Salary benchmarking and Business development services. The recruiter has stated that all applicants for this job should be able to prove thatthey are legally entitled to work in the UK and on this occasion TemplarFox Consultancy is acting as an employment agency.

Keyskills :
GMPLife CycleValidationCSVGxP

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