CSV Engineer Switzerland

Responsibilities

• Work with relevant Change Owners for all GxP IT systems to identify and mitigate risks, ensuring all changes are tracked to completion.
• Prepare and execute core CSV deliverables, including validation protocols, summary reports, and periodic system reviews.
• Provide technical assessment and system support for quality deviations and non-conformances.
• Recommend and manage Corrective and Preventive Actions (CAPAs) to enhance system compliance and performance.
• Author and maintain SOPs and work instructions governing the operation, maintenance, and compliance of software systems.
• Collaborate with IT and process owners to ensure the compliance of software systems throughout the entire system lifecycle.
• Ensure adherence to CSV procedures during system implementations and provide support for new software projects, including updates to the validation master plan.
• Serve as the subject matter expert for CSV during internal and external regulatory audits.
• Coordinate with the Validation department to align CSV processes with broader site validation policies and standards.
• Research and propose the implementation of new technologies to improve business and compliance processes.

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