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CQV Lead (m/f/o)Basel

  • +1
  • CH
    Visp, Valais, Switzerland
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  • +1
  • CH
    Visp, Valais, Switzerland

About

0 Teilen For an international pharmaceutical company located in VISP we are looking for a CQV Lead :
JOB DESCRIPTION
  • Provide leadership of CQV activities in assigned Projects together with PM, Process Engineers and QA
  • Act as subject matter expert (SME) on CQV standards
  • Correct CQV project staffing, expertise and coaching to the CQV staff assigned to projects
  • Initiate necessary training on CQV-Staff / Project staff on CQV and CSV (supported by local CQV -Staff)
  • Keep oversight on CQV -standards, -timelines (etc.)
  • Address immediate time/quality constraints and act adequately
  • Force RFT thinking and approach
  • Consider EHS Requirements
  • Develop and deliver CQV Documents Commissioning Documents (Suppliers / Process Engineers/EMR) QV-Documents (Suppliers / QV-Team /QA)
  • Responsible for ensuring that SGIE projects in Visp are compliant with the global CQV guidelines, aligned with local procedures and detect/resolve potential gaps in line with the company's continuous improvement vision
  • Participate in inspection as Project CQV-representative

    • ESSENTIAL REQUIREMENT / RELEVANT EXPERIENCE
  • Technical degree (bachelor level) in engineering or applied science, post graduate qualification preferred
  • Minimum of 10+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects. Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable.
  • Significant experience in regulated pharmaceutical industry and/or engineering company with proven experience on planning CQV activities, leading large senior reports and high understanding/management of KPIs.
  • Strong knowledge of ISPE and ASTM guidelines with proven experience on large and complex projects. Proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.
  • Experience in People Management (internal and external) with respect to organizational aspects, coaching and development. 
  • Solid collaboration and influencing skills and the ability to work together with teams and individuals in a high matrix environment.
  • Language: Excellent command of English
  • Strong analytical skills. Ability to conduct in-depth analysis of complex/large data sets, draw conclusions accordingly, and prepare and support decisions.
  • Experience at working both independently and in a team-oriented environment.
  • Ability to effectively prioritize and execute tasks in a fast-paced environment.
    • S TART DATE: February 2024
    END DATE: Until 31.12.2024 (high probability of extension)
    WORK LOCATION : 3930 Visp
    WORKLOAD: 100%


    INTERESTED?
    We look forward to your application via our homepage or direct to . Bewerben

    Arbeitsort

    Visp

    Branche

    Produktion Life-Sciences
    • Visp, Valais, Switzerland

    Work experience

    • General Project Management

    Languages

    • English
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