Description
- Provide QA support for computer system validation, equipment qualification with focus on laboratory instrumentation.- Apply risk based methodology to validation efforts
- Provide QA assessment and approval for GMP equipment and computer system changes
- Provide QA support for GMP equipment Periodic Review activities
- Provide QA support for Deviations and CAPAs
- Work closely with QA site support and QA Validation to assure alignment between Quality systems.
- Identify and implement process improvements
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
- Maintain routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Assist in identification of systematic problems within laboratory. Recommend resolutions for ongoing or recurring nonconformance.
- Evaluate scientific instrument calibration and maintenance records.
- Investigate technical problems, propose revisions, and contribute in the validation and qualification of technical procedures.