- Develop and execute IQ, OQ and PQ protocols for product, processes, facilities, software and equipment within the facility.
- Write reports summarizing results and statistics for all validation projects.
- Review existing validation reports and identifies gaps for compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
- Develop and communicate expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts.
- Monitor and drive corrective action and continuous improvement activities that directly impact performance measures.
- Provide day-to-day support to development, engineering and manufacturing for design control planning and design transfer activities.
- Ensure validation program meets requirements of regulatory compliance
- Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports. Coordinate with end users and process owners to resolve any identified issues to bring validation to acceptable levels.
- Learn and understand the applicable technology and engage in technical discussions.
- Identify areas and opportunities to improve manufacturing facilities, processes and equipment.
- Provide consultation to other departments performing QA validation activities
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