Description : Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
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- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.
- Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
- Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
- Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
- Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
- Resolve testing problems by modifying testing methods or revising test objectives and standards.
- Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
- Identify deviations from established product or process standards and provide recommendations for resolving deviations.
- Direct validation activities, such as protocol creation or testing.