QUALIFICATION, EXPERIENCE AND SKILLS REQUIRED

• Third level degree in a science/engineering subject as a minimum.
• Previous validation experience is advantageous .
• Good understanding and application of GMP and regulatory requirements.
• Experience of wide range of validations including equipment, cleaning and facilities validation plans.
• Excellent communication / interpersonal skills
• Attention to detail

MAIN DUTIES AND RESPONSIBILITIES:

• Design validation study features, such as sampling, testing, or analytical methodologies.
• Direct validation activities, such as protocol creation or testing.
• Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of problems.
• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
• Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.
• Review validation and compliance documentation, such as Process Flows, Training Records, or protocols.
• Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
• Prepare validation or performance qualification protocols for new or modified processes or equipment.
• Maintain validation test equipment by coordinating equipment Calibration requirements.