Quality Assurance and Validation Specialist

3 days ago


Galway, Galway, Ireland beBeeValidation Full time €60,000 - €80,000
**Quality Assurance and Validation Professional**

We are seeking a skilled Quality Assurance and Validation professional to join our team, working on medical devices in a dynamic and innovative environment. The ideal candidate has 3+ years of experience in validation/quality assurance, with a strong background in GMP regulations and knowledge of quality systems.

Key Responsibilities:
  • Validate site equipment, utilities, processes, and software in compliance with policies, FDA, European cGMP, and GAMP standards.
  • Develop and implement Site Validation Master Plans, Project Validation Plans, and schedules.
  • Generate validation protocols and final reports to cGMP standards.
  • Manage validation, exception event, and change control processes.
  • Maintain the overall cGMP compliance of production areas.
Required Skills and Qualifications:
  • 3+ years of experience in validation/quality assurance in medical device plastics processing, moulding or assembly operations.
  • Knowledge of cGMP and regulatory requirements relating to the medical device industry.
  • Degree in engineering or scientific discipline.


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