QA Expert Compliance

vor 3 Wochen

Basel, 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.

For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Stein and Visp 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 for the position as QA Expert Compliance.

Key responsibilities:

Drafts, negotiates and finalizes Quality Agreements with Suppliers and Service Providers

Ensures the proper qualification of material/service suppliers by supervising adherence to global QMS requirements

Interacts with the Global Supplier Qualification team by acting as local Point of Contact for the line units of Drug Product Services in both Basel and Stein

Supports establishment and maintenance of the Quality Management System at Drug Product Services (DPS) for QC in Basel and manufacturing plants in Stein

Prepares, reviews and approves GMP documents such as SOPs, Work Instructions for assigned topics

Supports customer audits and health authority inspections as required

Acts a system coordinator at local level for systems like DMS, Trackwise, SAP

Key requirements:

Academic degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related field

Solid working experience in Quality Assurance in pharmaceutical industries and GMP controlled environment preferable in production and/or analytics. Experience with supplier qualification is a plus.

Very good working knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems

Sound knowledge in compliance systems for document lifecycle management, training management and workflow tools (e.g. TrackWise)

Ability to handle complex situations successfully, and to define tasks self-reliantly after discussion with line manager

Highly organized work style to ensure multiple assigned projects can be handled in parallel

Very good knowledge of written and spoken English; German is a plus

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: R59609

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