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Inspection and Quality Assurance Leader
Vor 4 Tagen
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Quality Assurance Expert
vor 1 Woche
At Lonza, we are driven by a shared purpose – to improve lives. Our global leadership in life sciences spans across three continents. We pride ourselves on fostering a culture where talented individuals can collaborate and devise innovative solutions that help businesses make a positive impact.
About the Role:
- We seek a skilled Quality Assurance (QA) professional to define and approve specifications for raw materials, in-process samples, and APIs, ensuring compliance with quality standards.
- The ideal candidate will review and approve Standard Operating Procedures (SOPs), analytical methods, sampling protocols, assessments, equipment qualification, and method validation plans/reports from the QC department.
- This role requires expertise in driving deviation investigations in the QC area, overseeing change management processes for analytical methods and specifications, and ensuring timely closure of CAPA and Effectiveness Check items.
- The successful candidate will represent QA in project organizations, contribute technical expertise in transfers, and conduct internal and external audits, supporting customer audits and health authority inspections.
Requirements:
- Bachelor's or Master's degree in chemistry, biotechnology, life sciences, or a related field.
- A minimum of 3 years of experience in the pharmaceutical industry, preferably in QC or QA, with strong analytical expertise and method validation experience.
- Solid background in cGMP regulations, including USP, European, and Japanese Pharmacopoeia, with auditing experience and interactions with health authorities.
- Solution-oriented team player with excellent verbal and written English skills; German language knowledge is an advantage.
