Senior Quality Assurance Specialist
Vor 5 Tagen
As a Senior Quality Assurance Specialist at Lonza AG, you will play a critical role in ensuring the quality and compliance of our products and services. This is a challenging and rewarding opportunity to work in a dynamic and global environment.
Key Responsibilities- Quality Record Management: Own and manage quality records, including change controls, CAPAs, investigations, and effectiveness checks, in accordance with valid SOPs.
- Change Control Review: Lead the Change Control Review Board (CCRB) and CAPA Review Board (CRB) as required, ensuring timely and effective review of changes.
- Quality Support: Host change control clinics to support Production, MSAT, validation, CQV, and other Quality members with change controls.
- Document Control: Author, review, and approve GMP-relevant documents and SOPs in the ownership of QA.
- Audit Support: Support and participate in internal, customer, and regulatory audits, ensuring compliance with quality standards.
- Electronic Batch Record Management: Review and approve electronic batch records, including recipe review and approval.
- Continuous Improvement: Support continuous improvement programs to establish effective Quality Management Systems.
- Education: Bachelor or Master's degree in life sciences (e.g., chemistry, biotechnology, or a related field).
- Experience: Significant work experience in the GMP-regulated industry, preferably in Production, QC, or QA, Operations.
- Knowledge: Broad knowledge of quality standards (e.g., ICH Q7, 21 CFR Part 11) and electronic systems (e.g., Delta V, Syncade, SAP, LIMS, Trackwise).
- Language Skills: English language skills (written and spoken) are required, German is an advantage.
Lonza AG is a global leader in life sciences, operating across three continents. We are committed to improving lives around the world through our products and services. Our values include respect, protection, and responsibility towards our people and the environment.
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