CVQ Lead

Are you a CQV Lead interested in working for one of the most interesting names in High-Tech Biopharmaceuticals?

Are you looking for something new?!

Title: CQV Lead

Location: Visp, Switzerland

Rate: Open

Openings: 1 Lead

Contract/Perm: Contract (12-Months)

A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

Responsibilities:

• Provide leadership of CQV activities in assigned Project(s) at Visp (together with PM, Process
• Engineers, QA):
  • acting as subject matter expert (SME) on following the clients 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)
  • Keeping oversight on the clients CQV -standards, -timelines (etc.)
  • Address immediate time/quality constraints and act adequately
  • Force RFT thinking and approach
  • Considering EHS Requirements
• Involved and support PM and Process Engineers in CQV-Planning:
• Development and delivery of CQV Documents
  • Commissioning Documents (Suppliers / Process Engineers/EMR)
  • QV-Documents (Suppliers / QV-Team /QA)
• Activities:
  • Commissioning (Suppliers / EMR / Process Engineers / Process Owner)
  • QV (CQV-Team / Process Owner / 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 clients continuous improvement vision.
• Participate in inspection as the clients Project CQV-representative

Requirements:

• 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.
• Proven excellent communication and interaction skill

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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