QA Senior Specialist/ QA Lead
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 support the Quality operations department in Cell & Gene Therapy and is responsible for QA oversight for Supply Chain operations.
- General QA oversight for Supply Chain Management, specifically focusing on material release, Vendor change management, Supplier quality management.
- Monitor day-to-day Quality Assurance activities in accordance with approved SOPs /Policies for a multi-product contract manufacturing facility.
- Highly motivated individual and have superior skills in all areas relevant to the job.
- Member of cross-functional site team(s) on projects/ issues.
- Lead in complex deviation investigations, change controls, CAPA proposals and closure of discrepancy reports.
- Superior ability to troubleshoot.
- A competent Reviewer and Approver of SOPs, protocols, reports or records.
- Coordinate between departments for multiple parallel activities.
- Understanding of advanced topics pertaining to cGMP.
- Participate in Customer / Agency Audits and Inspections as required.
- Identify process pathway and work to develop improvement in strategy.
- Understand and articulate company business strategy. Maintain a broad view of the business, recognize changes and trend in the appropriate area in which the individual operates.
- Any other tasks as and when assigned by supervisor.
- Bachelor Degree in Science or Chemistry with relevant work experience in Quality Assurance in the Biopharmaceutical industry.
- Good understanding of GMP, Operation QA (manufacturing, plant) and close interaction with warehouses, Supply Chain.
- Experience in reviewing SOP, change control, setting up procedures, liaising with Supply Chain on issues and deviation investigation, etc.
- Candidate should ideally come with supplier QA experience (change management, impact, follow-up actions, approvals).
- Relevant 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.