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Digital QC Expert(m/w/x)

Merck KGaA
Corsier-sur-Vevey

Du leitest digitale Projekte für QC, implementierst neue Systeme und bist der digitale Botschafter für moderne Tools im Team.

Anforderungen

  • •CFC / BTS / University degree in Life Science
  • •4 to 9 years professional experience
  • •At least 2 years in LIMS administration
  • •Hands-on experience with computerized system validation
  • •Strong understanding of regulatory requirements
  • •Understanding of Quality Control workflows
  • •Passionate about innovation and digital transformation
  • •Excellent problem-solving skills
  • •Strong communication skills
  • •Ability to collaborate with international teams
  • •Well-organized with strong sense of responsibility
  • •Fluent in English (B2 or higher)

Deine Aufgaben

  • •Leite QC-Digitalisierungsprojekte in enger Zusammenarbeit mit dem Digital & Innovation-Team
  • •Bewerte und implementiere neue digitale Lösungen für die Qualitätskontrolle
  • •Verbessere kontinuierlich bestehende QC-Digitalsysteme
  • •Agriere als digitaler Botschafter für QC und fördere Innovation
  • •Konfiguriere GLIMS-Systeme gemäß Laboranforderungen und Branchenstandards
  • •Verwalte und halte QC-Stammdaten in GLIMS
  • •Biete erste Unterstützung und Schulung für QC-Teams als Hauptbenutzer
  • •Stelle die Systemleistung und Datenintegrität durch kontinuierliche Überwachung sicher
  • •Halte dich über aufkommende LIMS-Technologien und Branchentrends informiert
  • •Arbeite mit CSV-Experten und unterstütze die Qualifikationsaktivitäten für digitale Systeme
  • •Bereite Validierungsdokumente gemäß GxP-Anforderungen vor und führe sie aus
  • •Koordiniere mit QC, QA und IT zur Einhaltung der Vorschriften bei der Einführung von Systemen

Deine Vorteile

Vielfältige Perspektiven und Hintergründe
Umfassende Entwicklungsmöglichkeiten

Original Beschreibung

We are experiencing a technical issue with the Careers Website. At the moment, applications are not possible. We are working on resolving the issue as soon as possible. Thank you for your patience. # Analytical Op&QC Digital Expert - All Genders | | | --- | | Express your talent with us! Do you want to explore, overcome obstacles, and make discoveries? We know that your projects are ambitious. Ours are too! Around the world, our colleagues share a passion for scientific and technological innovation that enriches human lives through our solutions in Healthcare, Life Science, and Electronics. Together, we think big and are committed to caring for our diverse range of employees, customers, patients, and the planet. That’s why we are always looking for curious minds who wish to imagine the impossible with us. United for patients: the goal of the Healthcare division is to contribute to creating, improving, and prolonging lives. We develop medicines, smart devices, and innovative technologies in therapeutic areas such as oncology, neurology, and fertility. Our teams work passionately and curiously across all six continents to help patients at every stage of their lives. Joining our Healthcare team means participating in a diverse, open, and flexible professional culture that offers great opportunities for personal development and career advancement around the globe. | As a **Digital QC Expert** in the Biotech Development Center, you will be a key player in shaping and implementing digital solutions to support Quality Control (QC) activities across clinical Phase I & II development. You will lead initiatives for laboratory digitalization, support LIMS activities and drive qualifications related to computerized systems (CSV). Furthermore, you will act as a digital project lead within QC, working in close collaboration with our Digital & Innovation team to optimize processes, enhance data integrity, and ensure compliance with regulatory requirements. Your expertise in digital technologies and scientific workflows will contribute to driving operational efficiencies and facilitating data-driven decision-making. This role combines **technical expertise, project leadership, and operational support**, making you a central point of contact for QC digital topics in the Biotech Development Center. **Responsibilities:** **Digital Project Leadership** * Lead QC digitalization projects in close collaboration with the Digital & Innovation team, ensuring alignment with QC operational needs and compliance requirements. * Evaluate and implement new digital solutions tailored to Quality Control activities (e.g., Laboratory Execution System (LES), electronic documentation, data analytics, equipment integration). * Drive continuous improvement of existing QC digital systems. * Act as the digital ambassador for QC, fostering innovation and supporting the adoption of modern digital tools within the department. **GLIMS Masterdata & Routine Operations** * Configure GLIMS systems to meet laboratory requirements and industry standards. * Manage and maintain QC master data in GLIMS ensuring proper configuration. * Act as key user, providing first-line support, troubleshooting, training and access management for QC teams in routine. * Ensure system performance, data integrity, and audit readiness through continuous monitoring and alignment with GMP/GxP standards. * Stay updated on emerging LIMS technologies and industry best practices to drive continuous improvement and innovation. **CSV Computerized System Qualification** * Collaborate with CSV expert and support qualifications activities for QC related digital systems (e.g. Empower, SDMS, etc.). * Prepare and execute validation documentation (User Requirements, risk assessments, protocols, reports) in alignment with GxP requirements. * Coordinate with QC, QA, IT, to ensure compliant deployment of computerized systems. **Who you are:** * CFC / BTS / University degree in Life Science, Computer Science, Information Systems, or similar discipline. * 4 to 9 years of professional experience, including at least 2 years in the administration and configuration of LIMS or similar systems. * Hands-on experience with computerized system validation (CSV) and a strong understanding of regulatory requirements (GMP/GxP, data integrity). * Understanding of Quality Control workflows and processes. * Passionate about innovation and digital transformation, with a strong drive to explore new technologies and improve existing systems. * Excellent problem-solving skills and ability to troubleshoot technical issues. * Strong communication skills and ability to collaborate effectively with cross-functional international teams. * Well-organized and able to manage multiple tasks and projects simultaneously, with a strong sense of responsibility. * You are fluent in English (B2 or higher), German or French is a plus. **What we offer you:** we are curious minds from diverse backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and are convinced that it is the driving force behind excellence and innovation, strengthening our capability as a scientific and technological leader. We are committed to ensuring that everyone has access to rich development opportunities at their own pace. Join us in building a culture of inclusion and belonging that impacts millions of people and empowers everyone to express their talent and advance humanity! Job Requisition ID: 287930 Location: Corsier-sur-Vevey Career Level: D - Professional (4-9 years) Working time model: Full-time **North America Disclosure** The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance. **Notice on Fraudulent Job Offers** Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information. **Job Segment:** QC, R&D, Computer Science, Laboratory, Neurology, Quality, Research, Technology, Science, Healthcare
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