Senior QA Expert CSV / DI 80-100% (m/f/d)

Job title:

Senior QA Expert CSV / DI 80-100% (m/f/d)

Company:

Lonza

Job description

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.The primary objective of the role is to ensure proper timing in inspection preparation for a large CAPEX project (encompassing a fill and finish facility, laboratories, warehouse, shipping and offices). The role will manage qualification and validation activities to support the projects teams and objectives according to agreed deadlines and standards. Then, after the project phase, will manage qualification and validation activities to maintain the qualified/validated status of all GMP activities necessary to maintain commercial product batch activities.

ResponsibilitiesThis role will manage quality oversight for computerized systems validation and the data integrity program & support QA activities for system introduction/upgrades, ensuring compliance with quality policies, cGMP, EU/US, and Swiss regulations. Also, it will oversee daily quality for GxP IT, CSV, and automated systems (SISA). Specifically, this position will support all qualification and validation activities of computerized and automated systems (e.g. MES, PLC/SCAPA, EMS, LIMS, SAP) for DMS Lonza Stein within a project framework and in accordance with quality policies, GMP, EU/US regulations and Swiss regulations. Furthermore, the position will ensure close collaboration with other site functions and will drive compliance and continuous improvement while supporting Lonza’s overall CSV and DI strategy.Additionally, the role will require the following:Act as the primary QA contact for data integrity to the assigned areaReview/approve GxP IT, CSV and SISA SOPs to ensure regulatory complianceEnsure compliance with cGMPs and support Commissioning & Qualification activitiesReview/approve CSV related documents, design documentation, audit trails, deviations, investigations and CAPA plansAlign with Global QA CSV organization and support inspection readinessBeing an actor in raising the CSV/DI maturity of the site in accordance with the group strategyEnsure alignment with Global QA CSV organizationProfileAcademic degree in natural/applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering)Minimum 10 years in CSV/QA CSV with Quality experienceIn-depth knowledge of cGMP, international regulations, and validation activitiesExperience with international inspectionsStrong analytical, problem-solving, and communication skills.Ability to make pragmatic and compliant decisionHaving had experience with software such as TRACKWISE and KNEAT is an assetFluent in English, German is an assetEvery 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.

Expected salary

Location

Scapa, Orkney Islands – Switzerland

Job date

Wed, 28 Aug 2024 00:14:58 GMT

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