Specialist 1, QA
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 role will provide day-to-day Quality Assurance activities support in accordance with approved SOPs / Policies for a large scale GMP Biotech manufacturing facility.
- Review and approve change controls.
- Review and approve Master Batch Records (MBR), SOPs, protocols, reports or records.
- Support changeover activities.
- Ensure real-time decisions on process events on the floor based on knowledge of defined SOPs & policies.
- Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a large scale, multi-product, GMP biotech manufacturing facility.
- Develop in depth awareness of entire process; identifying operational factors which influence the process.
- Participates in Regulatory and Customer Audits.
- Lead and coordinate minor projects.
- Develops good working relationships with internal & external customers.
- Any other tasks as and when assigned by supervisor.
- Bachelor Degree with exposure in the Biopharmaceutical industry.
- Relevant experience from the Biopharma or any related environment.
- Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
- Knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
- Meticulous and Systematic.
- Team player, with strong focus on safety, quality and timelines.
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 achieve 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.