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Senior Validation Specialist
2 weeks ago
We are seeking a highly skilled Validation Engineer to join our client's team at their facility in Ireland.
Key Responsibilities:
- Coordinate the development and maintenance of site validation programs to ensure AbbVie and external regulatory requirements are met.
- Coordination, implementation, and active participation in the site Validation Program and general Quality Assurance activities.
- Generate/maintain/execute of Site Validation Master Plans and Project Validation Plans and schedules.
- Generate 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.
- Manage validation, exception event, and change control processes.
- Maintenance and tracking of validation equipment.
- Complete all required training before executing a task.
- Document all activities in line with cGMP requirements.
- Update validation procedures, job instructions, and batch documentation to reflect current best practices.
- Perform cross-training within the team and training of new team members.
- Participate in continuous improvement programs to implement improvements.
- Coordinate activities to maximize the effectiveness of all team members.
- Maintain overall cGMP compliance of production areas.
- Communicate with peers and management regarding activities in the area.
Essential Requirements:
- Qualification in engineering or scientific discipline.
- 3+ years of validation/Quality experience in medical device plastics processing, moulding, or assembly operations.
- 3+ years of knowledge of cGMP and regulatory requirements relating to the medical device industry.
- Strong communication, presentation, and troubleshooting skills required.
- Effective interpersonal and organizational skills.
- Ability to work well both independently and in a team environment.
- Capable of prioritizing work and multitasking.
Benefits:
This role offers an exciting opportunity to work in a fast-paced environment, collaborate with experienced professionals, and contribute to the success of our client's organization.
How to Apply:
For more information about this position, please contact us.
