CSV Engineer

3 weeks ago

Fordham Cambridgeshire, United Kingdom Resolian UK Full time

Responsibilities

  1. Oversight and Compliance :
  • IT CSV oversight for GXP computerized systems.
  • Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, OECD 17, GAMP 5).
  • Handling deviations, CAPAs, and change controls.
  1. Documentation and Review :
  • Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, traceability matrices, and validation summary reports.
  1. Collaboration :
  • Ability to work independently on validation projects but also collaborate with cross-functional teams (IT, QA, Operations).
  • Strong communication, problem solving and leadership in CSV processes.
  1. Issue Resolution and Communication :
  • Identifying and resolving system issues.
  • Communicating CSV requirements to senior management and stakeholders.
  1. Audit and Regulatory Support :
  • Supporting external audit programs for vendors.
  • Interfacing with regulatory agencies.
  1. Strategy and Improvement :
  • Developing and implementing CSV strategies, policies, and procedures.
  • Reviewing and approving validation documentation.
  • Resource coordination, monitoring, and tracking of validation activities.
  • Staying current with industry trends and regulatory changes.
  • Continuous improvement of the CSV process.
  • Flexibility and adaptability in a changing regulatory environment.

Education, Experience & Skills Required

  1. · Direct experience in leading, managing or participating in CSV projects in GxP environments.
  2. · B.Sc. degree in Computer Science, Chemistry, or a relevant scientific field with substantial relevant progressive experience (greater than 3 years).
  3. · Extensive experience in regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, and EU Annex 11 compliance requirements.
  4. · GLP /GCP /GMP experience is preferable.
  5. · Experience in supporting regulatory inspections.

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