This Role Is Responsible For
- Perform validation activities: Execute validation protocols for cleanrooms and HVAC systems, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
- Data collection and analysis: Collect and analyze data during validation activities, ensuring accurate and complete documentation of results.
- Documentation and reporting: Prepare validation reports and documentation in compliance with regulatory requirements and internal procedures.
- Troubleshooting: Identify and troubleshoot issues related to cleanrooms and HVAC systems during validation activities and propose appropriate corrective actions.
- Compliance: Ensure compliance with regulatory guidelines (such as FDA, GMP, and ISO standards) and internal quality systems during validation activities.
- Collaboration: Work closely with cross-functional teams, including engineering, quality assurance, and production, to coordinate validation activities and resolve any issues or discrepancies.
Continuous improvement: Identify opportunities for process improvement within the validation activities and contribute to the implementation of best practices.
