Senior QA Validator

1 week ago

Sligo, Sligo, Ireland beBeeQuality Full time €64,000 - €80,800
Job Opportunity

This is a senior-level QA validation specialist position where you will oversee the development and maintenance of site validation programs.

Main Responsibilities:
  • Oversight and active participation in validating site equipment, utilities, processes, and software to ensure compliance with quality standards.
  • Creation and upkeep of the Site Validation Master Plan, Project Validation Plans, and schedules.
  • Development of validation protocols and final reports that adhere to cGMP regulations.
  • Management of validation, exception event, and change control processes to maintain a high level of quality.
  • Maintenance and tracking of validation equipment to prevent delays and errors.
  • Detailed documentation of all activities according to cGMP requirements.
Required Skills and Qualifications:
  • Possession of a degree in an engineering or scientific field.
  • A minimum of 3 years of experience in validation/quality assurance within medical device plastics processing, moulding, or assembly operations.
  • Strong communication, presentation, and troubleshooting skills are essential for success in this role.

This position demands a thorough understanding of cGMP and regulatory requirements specific to the medical device industry.

The ideal candidate will be able to effectively communicate with peers and management regarding activities in the area, including reporting events or concerns.

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