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Critical Validation Expert

3 weeks ago

Cork, Cork, Ireland beBee Careers Full time
Critical Validation Expert Required

We are seeking an experienced Critical Validation Expert to join our team. The successful candidate will lead and execute validation activities for medical devices, ensuring full compliance with regulatory standards and quality system requirements.

Responsibilities:
  • Execute process and software validation activities in a regulated medical device environment.
  • Provide technical direction and support for the development, execution, and review of validation protocols and documentation.
  • Maintain up-to-date knowledge of current GMP and regulatory requirements.

Quality and Compliance
The Critical Validation Expert will be responsible for ensuring that validation practices meet internal quality standards and external regulatory requirements. This includes assisting in audits and inspections, providing validation documentation and expertise.

Qualifications and Experience
Candidates must have a Level 7 qualification (QQI) in Science, Electronics, Mechanical, or Industrial Engineering. A minimum of 2 years' experience in Quality Assurance or Regulatory Affairs is also required.