Aspen Global Inc.
Aspen Global Inc.
CURRICULUM VITAE
Accountable for leading the Computer System Validation function; building the team, developing its capabilities, and managing the departmental budget.
Act as document owner for all validation documents for all aspects of the software development life cycle, including SOPs, verification and validation
Act as the Subject Matter Expert (SME) for software verification and validation requirements, providing associated guidance and training to applicable staff.
Review and approve applicable software development & validation documentation, such as User Requirement Specifications, Technical Specifications, Test Protocols/Scripts, Verification and Validation protocols and reports.
Work collaboratively across the business to ensure that Validation-related processes and procedures are well-represented in regulatory submissions and responses to regulatory agencies.
Guide software development teams on risk management requirements, review & approve applicable risk registers.
Lead in the review, investigation and local approval of validation events/deviations, ensuring linkage to the Deviation & Corrective Action system where required.
Prepare and present software development & validation documentation during internal and external audits.
Maintain an active awareness of developments in regulatory standards and industry best practices that may impact validation requirements.
Maintain awareness of current and proposed best-practice regarding software design, development, testing & validation.
Ensure personal information privacy and security compliance best practice are integrated into software development, testing & validation.
Work with Technology & Development function to identify tools and methodologies to enable robust and efficient software development and testing, including automation.
Maintain the software validation library, ensuring all validated systems are listed.
Collaborate with the Technology & Development function to ensure that network & IT infrastructure meets regulatory requirements in terms of design and installation qualification.
Prepare and report KPIs/metrics regarding the software validation process in order to help maintain the effectiveness and improve the Integrated Management System.
Evaluate, and approve applicable software/technology suppliers and conducting vendor/supplier audits
Responding to external audits
Managing and leading external resources, including hiring, appraising and development
Hold additional responsibility of Business Continuity Co-ordinator for AGI (BCP and DR)
Achievements
Recognized as top talent and undergoing leadership training