Develop, implement, and manage computer system validation life cycle strategies to meet GxP and 21 CFR Part 11 requirements on time, on budget, and to ensure that programs are compliant with inspection agencies’ requirements.
Validation Master Plan – Establish and maintain a high level overview of the state of computer system validation across corporate divisions.
Gap Analysis/Assessment of Computer System Validation procedures.
Gap Analysis/Assessment of Computer System Validation documentation and related records.
Establish the computer system validation project prioritizations across corporate divisions.
Conduct vendor audits of software and technology providers supporting GxP activities.
Partner with Engineering, stakeholders, and team members across corporate divisions to ensure computerized systems compliance for all electronic record/electronic signature systems.
Establish and/or optimize the computer system validation life cycle approach for all validation deliverables to ensure compliance.
Establish and/or optimize best practices for validation test execution, documentation, and deviation handling.
Establish an escalation process to address difficult validation and software technical challenges.
Maintain all computer system validation activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections.
Provide guidance and governance on the computer system validation life cycle approach and drive harmonization / standards across divisions.
Ensure validation policies, SOPs, resources, and capabilities are in place across divisions to support technical transfers.
Provide guidance and support related to developing a budget for validation activities at divisional level.
Facilitate/coordinate global validation projects across sister sites.
Represent divisional activities relevant to validation (e.g. harmonization of standards).
Be a senior advisor for computer system validation compliance.
Ensure that all respective validation activities are performed and are in line with the current regulatory requirements, handling any associated deviations including oversight of validation resulting from major or complex changes.
Serve as the face-to-face point of interaction and / or support for external audits and regulatory inspections.
On-site or online training: Expand and share knowledge across sister sites. Provide Computer Systems Validation Basics Training and 21 CFR Part 11 & FDA Auditing of Computerized Systems Training across divisions and sister sites for personnel supporting GxP activities.