Site Validation Specialist

6 days ago

Sligo, Sligo, Ireland beBeeValidation Full time €60,000 - €80,000

Site Validation Specialist

To coordinate and oversee the development and maintenance of site validation programs ensuring regulatory, quality, and compliance requirements are met. Coordination, implementation, and active participation in the site validation program and general quality assurance activities.

Main Responsibilities

  • Coordinate and direct the validation and quality assurance of site equipment, utilities, processes, and software in compliance with policies, FDA, European cGMP, and GAMP standards.
  • Develop, maintain, and execute the Site Validation Master Plan.
  • Generate project validation plans and schedules.
  • Prepare validation protocols and final reports to cGMP standards.
  • Investigate validation issues and implement corrective actions.
  • Create, review, and approve various quality documents and test data.
  • Manage validation, exception event, and change control processes.
  • Maintain and track validation equipment, if applicable.
  • 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 train new team members.
  • Participate in continuous improvement programs to implement improvements in manufacturing, quality, safety, and training systems.
  • Coordinate activities to maximize the effectiveness of all team members.
  • Ensure overall cGMP compliance of production areas.
  • Communicate with peers and management regarding activities in the area, including elevation of events or concerns.

Required Skills and Qualifications

  • Bachelor's degree in engineering or scientific discipline.
  • At least 3 years of experience in validation/quality assurance with medical device plastics processing, molding, or assembly operations.
  • At least 3 years of knowledge of cGMP and regulatory requirements relating to the medical device industry.
  • Strong communication (written and oral), presentation, and troubleshooting skills.

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