CMO and Manufacturing Site CSV Audit Consultant

JOB DESCRIPTION

• Responsible for Computerized System Validation (CSV) audits for Contract Manufacturing Organizations (CMOs) and internal manufacturing sites.
• 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.
• 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 entity's 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.

Requirements

Who We Are :

The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.

Browse our website below for additional information on our company.

3407 W Martin Luther King Jr. Dr. Tampa, FL 33607

We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.

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