Quick Info
Job Type
Full TimeSpecialty Skills
Validation ProtocolsProcess ValidationEquipment QualificationCleaning ValidationComputer Systems ValidationSpreadsheet ValidationTemperature Profile MappingGMPRisk Assessment
About the Role
In this role you will be responsible for:
- 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.
- Conducting periodic lifecycle reviews for each of the validation disciplines.
- Supporting 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 toenable 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 criticaltemperature-controlled equipment
Process Improvement
- Work in collaboration with Quality Engineering and Operational Excellence toprovide validation and qualification expertise in improvement initiatives. Provide datavia validations to support product control plans and risk assessment processes.
- Take an active role in CAPA action teams, QE investigation teams and Kaizenevents where required.
Risk Assessment
- Identify via risk assessment, validation and qualification requirements for both newand changes to existing products, processes, equipment, cleaning procedures,computer systems and spreadsheets.
Other
- To undertake such other reasonable duties as may be required from time to time inorder to support the Perrigo business.