Junior QA Project Manager - Batch Record Review (m/w/d)
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.
Ibex® Solutions (www.ibex.lonza.com) is a modular build complex to develop and manufacture biological products. It enables companies to get access to a complete solution, gaining speed and achieving a simplified value chain. The Ibex® Complex is our contribution to the medicine of tomorrow and possibly the next step in your career? Start your career with Lonza today.
Currently we are looking for a Junior QA Project Manager - Batch Record Review (m/f/d) to join multinational QA Operations team at the Visp site. You will work closely with various quality and operational functions to ensure GMP-compliant manufacturing and documentation. You will also get exciting insights into our IBEX environment and can develop into QA project management role in perspective.
Independent implementation of the operational electronic batch record reviews (manufacturing protocols, cleaning protocols, etc.) in accordance with the internal work instructions
Represents QA in project/tech transfer organizations for new biotech manufacturing processes.
Responsible for review and final release of records such as Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, CAPAs, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
Authoring/approval of SOPs
Participates and supports regulatory inspections and customer audits
Actively supports the Quality culture as a role model
Bachelor in Biology, Chemistry, Biotechnology, Life Science or other related field
Previous experience in GMP regulated pharmaceutical industry is an advantage
Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
English and German good command are required
Ability to prioritize and manage work to critical project timelines in a fast-paced environment.
Excellent verbal, written and interpersonal communications skills
Excellent organizational skillsEvery 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.