Senior Validation Engineer Position Available

3 days ago

Sligo, Sligo, Ireland beBeeRegulatory Full time €60,000 - €80,000
**Job Description:**

Our organization seeks a Quality Assurance Specialist to join our team and ensure regulatory, quality, and compliance requirements are met. Coordination, implementation, and active participation in the site validation program and general quality assurance activities are essential.

The Quality Assurance Specialist will be responsible for:

  • Coordination/direction and active participation in the validation and quality assurance.
  • 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.

**Required Skills and Qualifications:**

To be successful in this role, you will need:

  • 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.
  • Effective interpersonal and organizational skills.
  • Ability to work well both independently and in a team environment.

**Benefits:**

As a Quality Assurance Specialist with our organization, you can expect:

  • A dynamic and collaborative work environment.
  • Ongoing training and development opportunities.
  • The chance to make a real impact on our organization's success.

**Others:**

Additional responsibilities may include participating in continuous improvement programs to implement improvements and coordinating activities to maximize the effectiveness of all team members.

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