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    Csv Specialist

    Katalyst Healthcares & Life Sciences
    3-7 years
    Not Disclosed
    Somerville
    15 June 10, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Quality Assurance/Computer System Validation (CSV) Leader

    Location: Crucell

    Summary:

    The Quality Assurance/CSV Leader provides compliance leadership, direction, and oversight to project teams in the area of Computer System Validation (CSV). This role is responsible for ensuring quality oversight of GxP regulated computerized systems and managing their release for GxP production use.

    Responsibilities:

    • Compliance Leadership and Oversight:
      • Provide compliance leadership, direction, and oversight to project teams in CSV.
      • Ensure quality oversight of GxP regulated computerized systems (e.g., manufacturing plant systems, laboratory systems, and enterprise applications).
      • Manage the release of regulated systems for GxP production use.
    • Review and Approval:
      • Participate in the review and approval of technical changes, Quality Incidents, CAPAs, and procedures.
    • Process Development:
      • Contribute to establishing and deploying processes, compliance-driven standards, and procedures.
      • Determine boundaries for harmonization and alignment versus differentiation.
      • Ensure processes and standards remain current with FDA and global regulatory requirements for GxP computerized systems.
    • Quality System Evaluation:
      • Evaluate the current Crucell quality systems for GxP computerized systems.
      • Implement improvements to comply with current FDA/EU standards.
    • Regulatory Guidance:
      • Provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 210, 211, 58, 820, 11, and EU Annex 11).
    • Project and Inspection Participation:
      • Lead and participate in project teams.
      • Participate in regulatory inspections and client audits.

    Requirements:

    • Education:
      • Bachelor's or Master's degree in Science, Computer Science, or a relevant area.
    • Experience:
      • Minimum of 7 years of relevant working experience in a pharmaceutical or biotechnology company.
      • Preferably 3 years in validation or QC, and in QA/CSV.
      • In-depth knowledge of computerized quality systems.
      • Experience with GMP inspections.
    • Knowledge:
      • Thorough knowledge of cGMP in manufacturing and R&D within GxP regulated industries.
    • Skills and Competences:
      • Communicative skills
      • Negotiation skills
      • Convincing
      • Team player
      • Accuracy
      • Problem solver

    About Crucell:

    Crucell is dedicated to ensuring compliance and quality in the manufacturing and use of GxP regulated computerized systems. Our mission is to align with FDA and global regulatory requirements, providing safe and effective solutions in the pharmaceutical and biotechnology industries.

    This structured format provides a clear and detailed overview of the position, responsibilities, requirements, and company background.

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