Full Time

Functional Expert CQV (APAC)

Posted 2 months ago
Application ends: October 17, 2021
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Job Description

China, Guangzhou

Singapore, Tuas Singapore

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Key Responsibilities

  • Provide leadership of CQV activities in assigned Project(s) in Singapore and China (together with PM, Process Engineers, QA):
    • Acting as subject matter expert (SME) on following Lonza 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 Lonza 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 are compliant with the global CQV guidelines, aligned with procedures and detect/resolve potential gaps in line with Lonza’s continuous improvement vision.
  • Participate in inspection as Lonza Project CQV-representative

Key Requirements

  • Minimum 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.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R34609


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