QA Manager for Qc

vor 2 Wochen

Visp, Schweiz Lonza Vollzeit

Switzerland, VispToday, 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.

As QA Manager Drug Product Ibex (f/m/d) you will represent Quality Assurance in cross-functional teams within the Drug Product organization. Including but not limited to Manufacturing, MSAT, QC, Engineering, Supply, Qualification / Validation and others to effectively execute GMP tasks related to Drug Product processes.

Key responsibilities:
**Functional responsibilities as QA for QC**:

- Review and approval of QC-related documents, for product analyses and environmental monitoring (e.g. SOPs, sampling plans, analytical protocols / reports, QC method qualification protocols / reports)
- Sample management and results approval in electronic systems (e.g. LIMS, MODA)
- Point of contact for questions or issues related to QC during manufacturing operations, during the conduction of audits (internal, customer, regulatory) and inspections

**General QA Operations responsibilities**:

- Ensure shop floor QA oversight (presence in cleanroom)
- Assess, review and approve quality records (e.g. SOPs, deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs)
- Provide GXP-related trainings to operations personnel (e.g. GMP, GDP)

Key requirements:

- Master Degree of Science in natural sciences, preferred in an Biotechnology-related area
- Significant work experience in the GMP regulated environment; preferably in the Manufacturing or QC environment, in relation to aseptic manufacturing
- Knowledge in the usage of Quality Systems and associated tools (e.g. LIMS, Trackwise, SAP)
- Experience working with stakeholders from different departments and on different management levels
- Fluent English language (written and spoken), German language skills are an advantage

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.

**Reference: R53761**:

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