- Preparation and execution of validation protocols according to the Validation master plan and schedule.
- Completion of Change control risk assessments.
- Supporting Improvement projects with technical input and participating in problem solving teams.
Main Duties and Responsibilities: 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 or equipment
- Work in collaboration with quality engineering and to provide process validation expertise in process and product improvement initiatives.
- Provide data via validations to support product control plans and risk assessment processes
- Work as a part a multifunctional team in conducting FMEA
- Identify via risk assessment validation requirements for now products and changes to product, processes and equipment.
- Knowledge of GMP and its application in validation and change management and improvement processes, ability to learn new regulations.
- Ideally experience of working in an environment employing some elements of lean management would be advantageous but not essential.