QA VALIDATION ENGINEER
To coordinate the development and maintenance of the site validation program and ensure AbbVie and external regulatory, quality, and compliance requirements are met. Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities.
Responsibilities
- 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.
Requirements
- 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
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