QC GMP Expert*in für NEXTLab (befristet auf 2 Jahre) — Roche

Full description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position As a QC GMP expert for NEXTLab, you are driving the “Digital QC” initiative in Basel/Kaiseraugst. Your focus is on creating user requirements for analysis methods and their digital implementation in NEXTLab. You accompany the entire process from conception and validation in eVAL to support for changes, deviations and CAPAs. In close coordination with the Business Process Experts and the laboratories, you ensure that the local implementation strategy is successfully implemented.

The possibility

• Demand analysis on site: You develop together with the QC analysts in Kaiseraugst and Basel User Requirement Specifications (URS) for NEXTLab recipes, collect all relevant information independently and structure it in a targeted manner.
• Service orientation: You act as a competent service provider and contact for the laboratories and the NEXTLab method developers at the Basel site.
• Change Management: In Veeva Vault, you create change applications to establish new digital processes and coordinate closely with the Business Process Expert (BPE) for NEXTLab and the Quality Assurance (QAfQC).
• Solution design: You design technical solutions for the digitalization of laboratory methods and present them to the respective specialist areas.
• Template development: You create and optimize method and LES templates for our QC functions and continuously develop existing standards.
• Documentation: You ensure systematic and complete documentation of all development activities.
• Validation & Training: You validate method recipes, carry out appropriate user training and operate proactive change management.
• Quality assurance: You implement corrective measures within the framework of deviations, audits or inspections of authorities and ensure compliance.
• Interface work: You work closely with the 1st level support for NEXTLab to ensure smooth operation.

Who you are

You are an experienced personality with integrity who recognizes complex relationships and quickly translates creative ideas into practical solutions. In addition to your curiosity about technological innovations, You have in-depth professional experience in the GMP environment, ideally supplemented by QC knowledge. Programming or development experience is a big advantage. You like to work independently into new systems and expand your knowledge proactively. As a basis, you have an apprenticeship as a laboratory technician, chemist or pharmacist with several years of practice – alternatively bring You have a science degree. In addition, You in particular about the following professional and personal competences:

• An open approach to new projects and highly independent, initiative and integrity with a high level of social competence
• Willingness to provide services and sense of duty
• GMP/GDP knowledge (mandatory), CSV knowledge (advantageous)
• Methodological thinking and good stakeholder management (in the global environment)
• Project Management Experience & Team Skills
• Interest in providing a centralised service at the interface between laboratories and IT
• Independent and self-responsible personality with high quality awareness
• Knowledge of German and English is mandatory (good in word and writing, mind). Level B2 and French language skills are advantageous

Apply now with your current CV and recent testimonials and become part of our team to shape the future together!

Who we are A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an equal opportunity employer.