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Senior CSV Specialist

WALKER COLE INTERNATIONAL LTD
Job LocationBraintree
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Walker Cole International is searching for a Senior CSV Validation Specialist to join a leading Bio-Pharmaceutical Organisation in the South East of the United Kingdom. As the Senior CSV Validation Specialist you will ensure the development, implementation, validation, and qualification of all GxP systems, including managing the Computer System Validation lifecycle, 21 CFR Part II and Data Integrity. Your responsibilities will be:

  • Perform CSV (computer software validation) assessments such as Data Integrity and qualifies such systems. This includes new system qualification and remediation of legacy systems.
  • Assist in the planning, implementation, and management of, information technology framework, computerized validation, quality systems, and IT Processes’ ensuring cGMP compliance is maintained.
  • Review and implement change to standard operating procedures (SOP’s), policies and procedures to create a framework for the validation of a high quality, effective computer system.
  • Participate in both inspections and audits as a subject matter expert with excellent verbal, written, and interpersonal communication skills.
  • Assist in equipment selection and specification as well as perform the qualification and validation of facility, utility and manufacturing equipment and/or laboratory instruments
  • Oversee Change Management with business partners from a system use perspective; identify and address business process touch points.
  • Prepare summary reports, deficiency/discrepancy reports, gap analysis, risk analysis, failure mode and effect analysis (FMEA), traceability matrices.
  • Assists with the development of documents including, Validation Master Plans (VMP), Computerized System Validation (CSV), System Design Specifications (SDS), Users Requirements Specifications (URS), and Detailed Design Specifications (DDS).
    • The successful candidate will have
  • Bachelors’ Degree in Engineering, Sciences, IT or related field
  • At least 5 years’ experience in a validating GxP pharmaceutical or biotechnology laboratory services, or pharmaceutical manufacturing environment is required.
  • Knowledge of cGMP, GAMP, 21 CFR Part II and Data Integrity Guidelines.
    • Required skills
  • CFR
  • Pharmaceutical Manufacturing
  • CSV
  • GAMP
  • GxP

    • Keyskills :
    CFR Pharmaceutical Manufacturing CSV GAMP GxP

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