Specialist - Data Integrity​/CSV

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Quality

Quality Control

Professional

Schaffhausen, Switzerland

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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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.

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.

Laboratory Computerized Systems Lifecycle:

• Ensure timely and cost-effective execution of software qualification, validation, and lifecycle activities for GMP-relevant laboratory computerized systems.
• Coordinate 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.
• Create, maintain, and update SOPs and work instructions within the assigned area of responsibility.

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

• Ensure compliance with applicable GMP, EHS, SOX, and internal procedural requirements associated with the role.
• Support and manage non-conformances, including technical assessment, documentation, impact or risk evaluation, and implementation of preventive and corrective actions (CAPAs).

• 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…