Responsibilities

• Review electronic systems data and documentation to verify compliance with regulatory standards, including 21 CFR Part 11.
• Draft, execute, and manage computer system validation documents (e.g., URS, FRS, Risk Assessments, IQ/OQ/PQ, Validation Summary Reports).
• Oversee configuration, validation, and change management of QA systems to ensure regulatory compliance.
• Collaborate with IT teams and software vendors to resolve issues, implement updates, and optimize system functionality.
• Troubleshoot and address discrepancies in electronic systems, initiating corrective actions as needed.
• Lead change control processes to support system modifications and implementation.
• Identify training needs for electronic systems and provide training to site personnel.
• Support regulatory filings, data inquiries, and system inspections.
• Drive process improvement initiatives to enhance system performance and data reliability.
• Promote awareness of compliance requirements through SOPs, guidelines, and training.
• Identify and escalate compliance risks to management for resolution.
• Develop and update SOPs, work instructions, and training materials for QA systems.
• Provide ongoing training and support to site personnel on system functionalities and best practices.
• Monitor system performance, analyze metrics, and recommend improvements.

Qualifications

• Bachelor's degree in a relevant field or equivalent experience.
• Proven experience in QA systems, validation, and regulatory compliance.
• Strong knowledge of FDA, ISO, GMP, and 21 CFR Part 11 regulations.
• Experience with system troubleshooting, change control, and process improvements.
• Excellent communication and training skills.

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