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. START 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 tkarrer@payroll-house.com. Bewerben Arbeitsort Visp Branche Produktion Life-Sciences