Senior QA, Change Control Specialist
vor 3 Wochen
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Senior QA, Change Control Specialist (m/f/d), VispClient:Location:Job Category:Other
Job Reference:78af58f862a0
Job Views:9
Posted:21.01.2025
Expiry Date:07.03.2025
Job Description:Today, Lonza is a global leader in life sciences operating across three continents. 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.
As a member of the QA Projects and Change Controls group in BioAtrium, the Change Control Specialist (f/m/d) supports in QMS GMP compliance (e.g. hosting CCRB, supporting raising and closure of changes), promotes the adherence and continuous improvement of Quality Systems and ensures Quality oversight in the specified area.
Key Responsibilities:- Own quality records such as change controls, CAPAs, investigations, effectiveness checks in line with valid SOPs.
- Lead the Change Control Review Board (CCRB) and CAPA Review Board (CRB) as required.
- Host change control clinics to support Production, MSAT, validation, CQV and other Quality members with change controls.
- Author, review and approve GMP-relevant documents and SOPs in the ownership of QA.
- Support and participate in internal, customer and regulatory audits.
- Electronic batch record: recipe review and approval.
- Support continuous improvement programs to establish effective Quality Management Systems.
- Bachelor or Master Degree in life sciences (e.g. chemistry, biotechnology or a related field).
- Significant work experience in the GMP-regulated industry; preferably in the following units: Production, QC or QA, Operations.
- Broad knowledge in Quality standards (e.g. ICH Q7, 21 CFR Part 11).
- Knowledge of electronic systems such as Delta V, Syncade, SAP, LIMS, Trackwise is an advantage.
- English language skills (written and spoken) are required, German is an advantage.
Every day, Lonza’s products and services have a positive impact on millions of people. 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.
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