Specialist 3, QA
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there is 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 QA Specialist will be responsible for performing day-to-day tasks of the QA Department in a GMP facility manufacturing clinical and commercial pharmaceutical products.
- Compile lot disposition packages and drive lot disposition activities to ensure timely release of product.
- Provide oversight to product status, including preparation of documents for shipping activities.
- Provide oversight to quality tag out system.
- Participate actively and approve deviation investigations, utilizing Root Cause Analysis tools to enable effective and timely closure of deviation investigations.
- Provide oversight to ensure correct implementation of CAPA based on deviation raised and ensure timely closure of CAPA.
- Support changeover activities.
- Ensure real-time decisions on process events on the floor based on knowledge of defined SOPs & policies.
- Display a good level of problem solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knowledge or field experience.
- Detect non-compliance with cGMP and GDP requirements and provide guidance on GDP corrections.
- 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.
- Participate in walk down and begin to provide usable feedback.
- Participates in Regulatory and Customer Audits.
- Leads and coordinate projects.
- Generally provide basic compliance support to staff in all departments.
- Develops good working relationships with internal & external customers.
- Any other tasks as and when assigned by supervisor.
- Bachelor Degree with relevant work experience in Quality Assurance in the Biopharmaceutical industry.
- Relevant QA Operations background from the Biopharma environment.
- Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
- Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
- Familiarity with Regulatory requirements and local Codes & Standards (e. g. , FDA, EMEA, andlCHQ7).
- 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.