CMO and Manufacturing Site CSV Audit Consultant, e-Compliance / IT Governance, QA

--

Responsible for Computerized System Validation (CSV) audits for Contract Manufacturing Organizations (CMOs) and internal manufacturing sites. Either take full responsibility for CSV audits within a GMP QA-led CMO and manufacturing site audits or independently conduct CMO and manufacturing site CSV audits.
Develop, manage and update CMO and internal manufacturing site CSV audit processes and procedures including SOP and associated templates and forms.
Experience auditing and verifying system accuracy, maintaining data integrity, supporting traceability, and ensuring audit readiness within a manufacturing production environment.
Experience with new technologies such as artificial intelligence (AI) and machine learning (ML) and be able to lead AI/ML-based CSV activities.
Balance a multiplicity of demands in a responsive, professional manner to assure e-Compliance team provides appropriate and timely support to meet business objectives.
Perform other related duties and assignments as required.
Responsibilities of CSV Audit in Manufacturing:
• Establish CMO and manufacturing site CSV audit processes and procedures, including SOPs and related templates and forms. Coordinate with GMP QA on the details of CSV audit roles and responsibilities.
• Confirm that the Risk-Based Validation is in place. Prioritize systems that have the greatest impact on product quality and patient safety.
• Verify comprehensive documentation. Records of all validation activities used to demonstrate compliance are maintained.
• Confirm integration with QMS. Align the CSV process with the entitys quality management system to ensure consistency.
• Ensure Periodic Reviews and Updates - Revalidate systems after upgrades or changes to maintain compliance.
• Confirm Employee Training procedures and training records. Ensure staff understand how CSV supports cGMP compliance.