Hybrid Work Model (3 days onsite / 2 days HO)
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.
The role:
The QA (Quality Assurance) Analytics Team is recruiting a dedicated person who wants to work as a Senior QA Specialist (m/f/d) in Analytics in a fast-growing and innovative environment. In this role you will be responsible for ensuring Quality oversight on GMP-relevant activities carried out by the Quality Control and Analytical Development (AD) departments.
This includes the review and approval of SOPs, analytical methods/specifications, and validation plans/reports assuring their compliance with Lonza’s standards, customer requirements, and health authority expectations. Moreover, as a Quality and Compliance representative, you are a key member of cross-functional project teams, e.g. for process transfers and new product introductions.
Key responsibilities:
Representing the QA concerns to the Quality Control (QC) department and ensuring that cGMP requirements and SOPs are followed.
Control and release of GMP relevant documents of the QC Review and approval of SOPs, analytical test methods, method transfer protocols/reports and method validation protocols/reports, OOx iLab investigation issued by the QC/AD departments.
QA supervision for OOXs events during investigation in QC/AD: Review and approve Out-of-Specifications/-Expectations/-Trend results.
Write or revise SOPs in the area of expertise and ownership of these documents.
Ensuring compliance with cGMP in the areas of stability testing and reference standards.
Cooperation, review, and approval of deviations (DRs), Investigations (INV), changes (CRs), and CAPAs within analytics (QC).
Participating in customer Audits and Inspections.
Key requirements
Academic degree in Chemistry / Biotechnology/ Life Science or any related field.
Significant experience in the pharmaceutical industry; preferably in a QC or QA function.
Founded analytical expertise and experience with analytical method validation.
Strong background in cGMP regulations; incl. USP, European and Japanese Pharmacopoeia.
Auditing experience and experience in the interaction with health authorities (FDA, Swissmedic, etc.).
Excellent verbal and written communication skills in English, German language knowledge is advantageous.
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.
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What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
