Support the validation of new production lines, ensuring processes, systems, and equipment meet quality, food safety, and regulatory standards before operational start-up.
Assist in implementing a structured validation and qualification approach, including process validation, equipment qualification, and method validation, aligned with corporate and regulatory requirements.
Contribute to the deployment of Quality by Design principles, supporting the integration of quality into process design, material selection, and facility layout.
Support the development and implementation of the Quality Management System (QMS) for the new site (KORE, ISO, GMP), including document management, validation standards, change management processes, and traceability frameworks.
Participate in the design and set-up of laboratory capabilities, including selection of analytical methods, equipment, and qualification of laboratory systems.
Assist in managing change control activities to ensure the controlled implementation of new processes and systems.
Support supplier and material qualification processes before approval.
Participate in design review activities for process flows, equipment specifications, and capital project decisions from a quality standpoint.
Provide quality input within cross-functional project teams to support compliant system design.
