QA Expert

vor 3 Wochen

Basel, Schweiz Lonza AG Teilzeit
Switzerland, Basel

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.

ForDrug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, 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 Senior QA Expert/Specialist Instrument Qualification (m/f/d).

Key responsibilities:

  • Ensure that all lab instruments at DPS are in compliance with Lonza procedures and governmental regulations

  • Act as the QA point-of-contact for our stakeholders at Lonza DPS

  • Review and approval of lab instrument related quality records (e.g. Change control, CAPA, Deviation) and controlled documents (e.g. SOPs, Qualification Documents, Forms) at DPS

  • Ensure adherence to lab instruments related DPS GMP procedures, Lonza Global and Group procedures, governing regulations and industry guidelines

  • Provide strategic direction and guidance for lab instrument lifecycle management processes in line with GMP and LEAN principles

  • Support and guide a team of QA experts

  • Track, follow-up, trending and reporting on the GMP status of quality records, service providers and lab instruments

  • Provide support and guidance to other groups at Lonza when needed (e.g. projects, audit-support, service agreements)

Key requirements:

  • Bachelor / Master Degree in natural sciences (e.g. Chemistry, Engineer, natural science or related field.)

  • Significant experience with (computerized) lab instrument qualification, quality records and controlled document life cycle management, working in a EU and US GMP regulated environment

  • Familiarity with ISPE GAMP5 Guide and USP 1058 required

  • Experience in the usage of LIMS, DMS, Trackwise, SAP, ELN

  • Excellent knowledge of written and spoken English

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: R59692Apply Similar JobsR58117 Switzerland, Basel

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