Quality Assurance Specialist for Life Sciences
Vor 4 Tagen
We are seeking a highly skilled Quality Assurance Specialist to join our team in BioAtrium. As a member of the QA Projects and Change Controls group, you will play a crucial role in ensuring QMS GMP compliance and promoting the adherence and continuous improvement of Quality Systems.
Key Responsibilities- Owns quality records such as change controls, CAPAs, investigations, and effectiveness checks in line with valid SOPs.
- Leads the Change Control Review Board (CCRB) and CAPA Review Board (CRB) as required.
- Hosts change control clinics to support Production, MSAT, validation, CQV, and other Quality members with change controls.
- Authors, reviews, and approves GMP-relevant documents and SOPs in the ownership of QA.
- Supports and participates in internal, customer, and regulatory audits.
- Electronic batch record: recipe review and approval.
- SUPPORTS CONTINUOUS IMPROVEMENT PROGRAMS TO ESTABLISH EFFECTIVE QUALITY MANAGEMENT SYSTEMS.
- Bachelor or Master's 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.
LONZA IS A GLOBAL LEADER IN LIFE SCIENCES OPERATING ACROSS THREE CONTINENTS. OUR MISSION IS TO IMPROVE LIVES ALL AROUND THE WORLD BY PROVIDING HIGH-QUALITY PRODUCTS AND SERVICES. WE BELIEVE IN THE IMPORTANCE OF ENSURING THE HIGHEST LEVEL OF QUALITY IN EVERY ASPECT OF OUR BUSINESS.
Our commitment to quality is reflected in our state-of-the-art facilities, cutting-edge technology, and rigorous quality control processes. We are proud of our reputation as a trusted partner to the pharmaceutical, biotechnology, and healthcare industries.
If you are passionate about quality and committed to excellence, we encourage you to apply for this exciting opportunity to join our team.
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