QA VALIDATION ENGINEER

• Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with AbbVie policies, FDA, European cGMP and GAMP standards.
• Generation/maintenance/execution of the Site Validation Master Plan.
• Generation/maintenance/execution of Project Validation Plans and schedules.
• Generation of validation protocols and final reports to cGMP standards.
• Generation of validation investigations and implementation of corrective actions.
• Creation/Review/Approval of various quality documents and test data.
• Management of validation, exception event, and change control processes.
• Maintenance and tracking of validation equipment, if applicable.
• Completing all required training before executing a task.
• Documenting all activities in line with cGMP requirements.
• Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
• Performing cross training within the team and training of new team members.
• Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
• Coordinating activities to maximize the effectiveness of all of the team members.
• Maintaining the overall cGMP compliance of the production areas.
• Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

• Qualification and/or degree in engineering or scientific discipline.
• 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations.
• 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry.
• Strong communication (written and oral), presentation and troubleshooting skills required

Cpl Group