Senior Quality Assurance Specialist
vor 3 Wochen
At Lonza, we're driven by a passion for life sciences and a commitment to excellence. As a member of our QA Projects and Change Controls group, you'll play a critical role in ensuring the quality and integrity of our products and services.
As a Change Control Specialist, you'll be responsible for supporting QMS GMP compliance, promoting the adherence and continuous improvement of Quality Systems, and ensuring Quality oversight in the specified area.
Key responsibilities include:
- Ownership of quality records such as change controls, CAPAs, investigations, and effectiveness checks in line with valid SOPs
- Leading the Change Control Review Board (CCRB) and CAPA Review Board (CRB) as required
- Hosting change control clinics to support Production, MSAT, validation, CQV, and other Quality members with change controls
- Authoring, reviewing, and approving GMP-relevant documents and SOPs in the ownership of QA
- Supporting and participating in internal, customer, and regulatory audits
- Electronic batch record: recipe review and approval
- Supporting continuous improvements programs to establish effective Quality Management Systems
Key requirements include:
- 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 (an advantage)
- English language skills (written and spoken) are required; German is an advantage
At Lonza, we're committed to making a meaningful difference in people's lives. We're a global leader in life sciences, operating across three continents. Our people are our greatest asset, and we empower them to own their careers and make a real impact.
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