Description Overview
In this role you will be responsible for the preparation and execution of validation protocols according to the Validation master plans and schedules in Process Validation (including Performance Qualification, product hold time and transport studies), Equipment Qualification, Cleaning Validation, Computer Systems Validation, Spreadsheet Validation and execution and reporting of temperature profile mapping for Quality Critical equipment
You will also conduct periodic lifecycle reviews for each of the validation disciplines, and support Improvement projects with technical input and participating in problem solving teams (e.g CAPA, Quality Event, Kaizen).
Scope of the Role
Validation
• Generate and assist in the completion of qualification and validation protocols to enable the compliant and efficient introduction of new or changed products, processes, equipment, computer systems, spreadsheets and cleaning procedures.
• Report results and findings following execution of protocols.
• Conduct lifecycle reviews for products/processes, equipment, cleaning processes, computer systems, spreadsheets and temperature profiles for quality critical temperature-controlled equipment
Process Improvement
• Work in collaboration with Quality Engineering and Operational Excellence to provide validation and qualification expertise in improvement initiatives. Provide data via validations to support product control plans and risk assessment processes.
• Take an active role in CAPA action teams, QE investigation teams and Kaizen events where required.
Risk Assessment
• Identify via risk assessment, validation and qualification requirements for both new and changes to existing products, processes, equipment, cleaning procedures, computer systems and spreadsheets.
Other
• Undertake such other reasonable duties as may be required from time to time in order to support the Perrigo business.
Experience Required
Validation Technician • Braunton, GB
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