Site Validation and Assurance Expert

3 days ago

Sligo, Sligo, Ireland beBeeValidation Full time €50,000 - €80,000
Job Title: Site Validation Specialist

Job Description:
To coordinate the development and maintenance of site validation programs and ensure regulatory, quality, and compliance requirements are met. This involves coordination, implementation, and active participation in site validation and general quality assurance activities.

Responsibilities:
- Coordination and direction of site validation and quality assurance to ensure compliance with regulatory standards.
- Generation, maintenance, and execution of Site Validation Master Plans, Project Validation Plans, and schedules.
- Generation of validation protocols and final reports to regulatory standards.
- 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 regulatory 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 team members.
- Maintaining overall regulatory compliance of production areas.
- Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

Requirements:
- Qualification and/or degree in an engineering or scientific discipline.
- At least 3 years of experience in validation/quality assurance in medical device plastics processing, moulding, or assembly operations.
- Strong communication (written and oral), presentation, and troubleshooting skills required.

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