Job type: Durée indeterminée
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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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Deadline: 13-05-2024
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