Quality Assurance Specialist

1 week ago

Sligo, Sligo, Ireland beBeeValidation Full time €64,000 - €87,000
Key Position: QA Validation Engineer

We are seeking a skilled professional to play a key role in the development and upkeep of our site validation program, ensuring all regulatory, quality, and compliance requirements are met.

Key Responsibilities:

  • Coordinate, oversee, and participate in the validation and QA of site equipment, utilities, processes, and software in compliance with FDA, European cGMP, and GAMP standards.
  • Develop, maintain, and execute the Site Validation Master Plan.
  • Prepare validation protocols and final reports to cGMP standards.
  • Conduct validation investigations and implement corrective actions.
  • Create, review, and approve quality documents and test data.
  • Manage validation, exception event, and change control processes.
  • Maintain and track validation equipment, where applicable.
  • Complete all required training before performing any task.
  • Document all activities in line with cGMP requirements.
  • Update validation procedures, work instructions, and batch documentation to reflect best practices.
  • Provide cross-training within the team and support the training of new members.
  • Participate in continuous improvement initiatives for manufacturing, quality, safety, and training systems.

Requirements:

  • Qualification and/or degree in an engineering or scientific discipline.
  • 3+ years' validation or quality experience in medical device plastics processing, moulding, or assembly operations.
  • 3+ years' knowledge of cGMP and regulatory requirements relating to the medical device industry.
  • Strong written and verbal communication, presentation, and troubleshooting skills.
  • Effective interpersonal and organisational abilities.
  • Able to work both independently and as part of a team.
  • Capable of prioritising tasks and managing multiple responsibilities simultaneously.

About this role:

This is an exciting opportunity to join our organisation and contribute to the success of our site validation program.

What we offer:

A dynamic working environment, opportunities for career growth and development, and a competitive remuneration package.

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