Senior QA Expert for QC 80

vor 1 Tag

Stein, Schweiz Lonza Vollzeit

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.

Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers 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 for the position as a QA Expert for QC in order to support our new sterile Drug Product facility in Stein

Key responsibilities:

  • Provides guidance and quality oversight for biologics, small molecule, ATMP and ADC commercial drug products.
  • Represents the QA support and guidance to the Quality Control (QC) department and ensures that GMP requirements are met 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 department.
  • QA supervision for OOXs events during investigation in QC: Review and approve Out-of-Specifications/-Expectations/-Trend results
  • Write or revise SOPs in the area of expertise and be the owner of these documents.
  • Ensures compliance with GMP 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)
  • Support QA for QC raw data review, as deemed required
  • Release of samples/test results in LIMS, as deemed required
  • Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory GMP guidelines, health authority guidance, SOPs, HSE, etc.)
  • Perform/support inspections and audits as required.
  • Performs other duties as assigned.

Key requirements:

  • Bachelor, Master degree or PhD in chemistry, biotechnology, life science or related field.
  • At least 7-10 years of experience in the pharmaceutical industry, preferably in a QC or QA function.
  • Strong analytical knowledge expertise and experiences with analytical method validations.
  • Strong background in cGMP regulations, including USP, European and Japanese Pharmacopoeia.
  • Profound knowledge in laboratories/laboratory equipment qualification/validation.
  • Auditing experience and experienced in the interaction with health authorities (FDA, Swissmedic, etc.).
  • Solution-oriented and strongly team-minded. Ability to oversee project execution to identify non-compliance from quality standards.
  • Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
  • Excellent verbal and written communication 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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