Found Description
Responsibilities
- Plan, develop, and execute validation protocols (IQ/OQ/PQ) for eDHR systems and related equipment.
- Ensure validation activities meet regulatory standards such as FDA 21 CFR Part 11 and ISO 13485.
- Conduct performance testing and document results to confirm system functionality and reliability.
- Ensure eDHR systems comply with internal quality standards and external regulations.
- Collaborate with Quality Assurance teams to align validation efforts with broader quality goals and participate in audits.
- Validate that eDHR systems accurately capture and store production data in real‑time, monitoring data integrity across the manufacturing lifecycle.
- Author and maintain validation documentation, including protocols, reports, and SOPs.
- Record and analyze test data, identify anomalies, and prepare detailed reports for internal review and regulatory submissions.
- Work with IT, OT, manufactur...