GCP Compliance Specialist

Vor 4 Tagen

Vevey, Waadt, Schweiz ADM Vollzeit

We are looking for a highly experienced GCP Compliance Specialist to join our team in Lausanne.

Key Responsibilities
  • GCP Compliance
    • Develop and implement procedures to ensure GCP compliance throughout our clinical trials.
    • Provide expert GCP guidance to our clinical development teams.
  • Quality Event Management
    • Support stakeholders in managing quality events, including investigations and root cause analyses.
    • Assist in the development and implementation of CAPAs to address identified quality issues.
  • Vendor Qualification and Oversight
    • Conduct thorough qualification assessments of clinical vendors to ensure compliance with regulatory requirements and internal processes.
    • Collaborate with vendor QA representatives to ensure effective oversight and continuous monitoring.
  • Audit and Inspection Preparation
    • Prepare our teams for audits, including site and vendor audits, regulatory inspections, and internal audits.
    • Collaborate with stakeholders to review CAPAs related to audits and inspections.
Requirements
  • University Degree in Sciences or relevant academic background.
  • 6-8 years' experience in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years within Clinical Quality Management System & Compliance.
  • Experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites, and CSR).
  • Excellence knowledge of GCP. Current and strong working knowledge of GCP, CFR Title 21, and regulatory guidance including ICH quality, clinical, multidisciplinary guidance documents, and 21 CFR Part 11 compliance.
  • Strong experience in the mechanism of multiple QA vendor oversight.
  • Experience in setting and updating SOPs.
  • Knowledge of computerized systems validation.
  • Rigor, flexibility, adaptability, and organization.
  • Pragmatism focused on efficiency and continuous improvement.
  • Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities.
  • Fluent in English.

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