Senior QA Specialist, QA Analytics

Represent the QA concerns to the Quality Control (QC) and Analytical Development (AD) departments and ensures that GMP requirements are met and SOPs are followed. Control and release of GMP-relevant documents of the QC / AD. Review and approval of SOPs, analytical test methods, method transfer protocols/reports, method validation protocols/reports, and OOX gLIMS investigations issued be the QC/AD departments. QA supervision of OOX events during investigation in QC/AD departments: Review and approve Out –of-Specifications/-Expectations/-Trend results. Write or revise SOPs in your area of expertise and be the owner of these documents. Ensure compliance with GMP in the areas of stability testing and reference standards. Cooperation, review and approval of deviations (DRs), Investigations (INVs), changes (CRs), and CAPAs within analytics (QC). Support inspection/audit. Ensure compliance of Lonza QC test methods with Pharmacopoeias where applicable.

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

• Academic degree in Chemistry/Biotechnology/Life Sciences or related field

• Significant experience in the pharmaceutical industry; preferable 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 in English; German language knowledge is advantageous.