QA Expert Analytics, Drug Product Services
vor 20 Stunden
QA Expert Analytics, Drug Product Services (m/f/d) - Temporary
QA Expert Analytics, Drug Product Services (m/f/d) - TemporaryApply locations CH - Basel time type Full time posted on Posted 3 Days Ago job requisition id R65372
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. 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. And that’s the kind of work we want to be part of.
For Drug Product Services (DPS), our successful DP focused branch located in Basel, Switzerland, we have exciting opportunities Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying to a 6 month fixed-term contract as QA Expert Analytics, Drug Product Services (m/f/d)
Key responsibilities:- Provides support to QC functions (clinical and commercial) in GMP compliance related issues in area of expertise.
- Ensures corresponding elements of the corporate GMP Quality Manual are appropriately implemented and followed in Drug Product testing sites.
- Performs review and approval of documents related to validation of methods, specifications, release, and stability testing in electronic systems like LIMS, iLab, or DMS.
- Reviews changes requests, OOS, deviation reports, and CAPAs related to products and process.
- Writes, reviews, and approves deliverables (e.g., procedures, SOPs, gap assessments) to ensure GMP compliance.
- Performs/supports inspections and audits as the need arises.
- Academic degree (Master or higher) in Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
- Over 5 years of working experience in Quality Assurance in pharmaceutical industries and cGMP controlled environment, preferably in QC.
- Proven understanding of EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems.
- Sound knowledge in testing of biological drug products.
- Excellent communication and decision-making skills with the ability to work independently in a team environment.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, 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. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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