Team Lead QA, Batch Record Review (m/f/d)

☞ CH12 Lonza AG

View: 144

Update day: 04-04-2024

Location: Visp Valais VS

Category: Quality Assurance / Quality Control

Industry: Human Resources Services

Position: Mid-Senior level

Job type: Full-time

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Job content

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.The Team Lead QA, Batch Record Review (m/f/d) will be managing a team of QA batch record reviewers for Ibex Solutions Mammalian Single Use. The Team Lead ensures that the manufactured products comply with national and international requirements and cGMP standards over their entire life cycle. As a Quality and Compliance representative the Team Lead will be a key member in cross-functional project teams. Ensuring that measures for product safety, product quality & cGMP compliance are implemented.Key Responsibilities
  • Manage a middle sized team of QA Specialists for batch record review
  • Responsible for review and closure of executed MES batch records
  • Take part in internal meetings and make quality decisions for the respective projects
  • Responsible for review and final release of records like Standard Operating Procedures (SOPs), Deviations, Change Requests and Effectiveness Checks
  • Support and participate in customer audits and health authority inspections
  • Ensure an efficient cGMP compliant life cycle management of all manufactured products
  • Support cGMP training programs to ensure the staff is being trained
  • Train and mentor junior Lonza employees to better accomplish and perform in their duties as Quality professionals
  • Actively support the Quality culture as a role model
Key Requirements
  • Bachelor degree in Chemistry, Biotechnology or any Life Science related field
  • Significant experience in the GMP regulated pharmaceutical industry; preferably in a QA role
  • Strong background in cGMP regulations
  • General knowledge of manufacturing processes and analytical methods
  • Excellent verbal and written English. German language skills are an advantage
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.
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Deadline: 19-05-2024

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