Aktuelle Jobs im Zusammenhang mit Risk Management and Quality Control - Vevey, Waadt - ADM


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Risk Management and Quality Control

vor 2 Wochen


Vevey, Waadt, Schweiz ADM Vollzeit

Are you a detail-oriented professional with a passion for quality and collaboration?

We are seeking a Risk Management and Quality Control specialist to join our team in Lausanne.

Key Responsibilities
  • Risk Management
    • Identify and assess study-specific risks and critical data/processes.
    • Develop and generate Key Risk Indicators (KRIs) for studies.
    • Monitor KRIs on a monthly to quarterly basis through analytics and provide insights to stakeholders.
  • 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.
  • 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.
  • Team Training and Compliance Oversight
    • Ensure our Clinical Trial Team (CTT) remains up to date with protocol training and study-specific updates.
    • Provide training and awareness sessions to stakeholders on GCP compliance, risk management, and quality oversight.
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.