CQV Lead (m/f/o)Basel

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