Deine Übereinstimmung

Skills

Data AnalysisContinuous improvementData integrityTechnical supportComplianceGood Manufacturing Practice (GMP)Project management softwareCross-Functional LeadershipQuality control in constructionTroubleshooting coordinationSOP-ErstellungRisk Management

Sprachen

EnglischDeutsch

Die Stelle

We are searching for a passionate individual to join our Quality Control team us as a Specialist - Data Integrity / CSV (80-100%) in Schaffhausen , Switzerland. Purpose: You will take responsibility for laboratory computerized systems and analytical software used in regulated laboratory operations. This covers Windows endpoints, application servers, validated analytical software, user access controls, system documentation, and related lifecycle activities Acting as a key interface between Quality Control, Quality Assurance, IT, vendors, and laboratory users you will ensure that our computerized laboratory systems remain compliant, reliable, future-ready and fit for GMP use throughout their lifecycle.

01Laboratory Computerized Systems Lifecycle: Ensure timely and cost-effective execution of software qualification, validation, and lifecycle activities for GMP-relevant laboratory computerized systems.

02Coordinate software qualification, validation, administration, and lifecycle activities for laboratory systems in collaboration with business departments, Quality Assurance, global and local IT, vendors, and other relevant stakeholders.

03Create, maintain, and update SOPs and work instructions within the assigned area of responsibility.

04Support and execute cross-functional projects related to laboratory equipment qualification, analytical software implementation, Windows lifecycle activities, system upgrades, and infrastructure changes.

05Provide technical support and troubleshooting for laboratory IT incidents, analytical software issues, Windows-related problems, vendor support activities, and business continuity topics affecting GMP laboratory operations.

06Ensure compliance with applicable GMP, EHS, SOX, and internal procedural requirements associated with the role.

07Support and manage non-conformances, including technical assessment, documentation, impact or risk evaluation, and implementation of preventive and corrective actions (CAPAs).

Anforderungen

↳Ph.D., Master’s degree, or comparable qualification in natural sciences, computer science, engineering, or a related field; equivalent practical experience in a GMP laboratory, CSV, laboratory IT, or data integrity environment may also be considered.

↳Relevant experience in at least one of the following areas: laboratory equipment qualification and software validation within a GMP-regulated environment; or laboratory IT and system administration in a quality-controlled laboratory setting.

↳Additional IT experience, such as Windows administration, analytical software administration, user access management, application troubleshooting, or collaboration with IT support organizations or external vendors, is considered an advantage.

↳Experience with Quality Risk Management in accordance with ICH Q9, including data and process mapping.

↳Strong understanding of data integrity and data governance principles, with the ability to apply them in GMP-relevant laboratory processes and computerized systems.

↳Experience contributing to or coordinating cross-functional projects, ideally involving laboratory systems, software implementation, infrastructure changes, or compliance-related improvements.

↳Experience in managing non-conformances, preparing impact assessments, and implementing CAPA actions.

↳Proficient use of Microsoft Office applications and standard business productivity tools.

↳Excellent organizational and communication skills, a goal-oriented working style, and a strong can-do mindset.

↳Good command of English, including the ability to read, write, and review technical and GMP-relevant documentation; good command of German will be an added advantage.

Vorteile

＋Opportunities to shape laboratory innovation in a global company at the forefront of healthcare

＋Accessible location in beautiful Schaffhausen

＋Collaborative, inclusive work environment that values work-life balance, cross-functional teamwork, and continuous improvement

Technologien

Windowsanalytical softwareMicrosoft Office

Unternehmen

Johnson & Johnson / Janssen

Healthcare

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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