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.