CQV Lead

European Recruitment are supporting a Consultancy company in their search for a CQV Lead in Valais, Switzerland to manage CQV Engineers, define and assign CQV staff, lead the CQV Team and generate CQV timelines.

Responsibilities:

• Act as subject matter expert (SME) on following Customer 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.
• Keeping oversight on Customer CQV -standards, -timelines.
• Address immediate time/quality constraints and act adequately.
• Force RFT thinking and approach.
• Considering EHS Requirements.

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.

By applying to this role you understand that we may collect your personal data, store and process it on our systems. For more information please see our Privacy Notice.

(https://eu-recruit.com/about-us/privacy-notice/)