Pharmaceutical Quality Assurance Specialist

2 days ago

Sligo, Sligo, Ireland beBeeValidation Full time €55,000 - €85,000
Quality Assurance Validation Engineer

The position is based in Ireland, where our pharmaceutical client is located on the picturesque west coast. Our global client has invested significantly in research to discover and develop new medicines. They have a large team of employees around the world and are continuing to grow.

Key Responsibilities:
  • Ensure site equipment, utilities, processes and software are validated and comply with policies, FDA, European cGMP and GAMP standards.
  • Develop and maintain Site Validation Master Plans, Project Validation Plans and schedules.
  • Generate validation protocols and final reports to cGMP standards.
  • Investigate validation issues and implement corrective actions.
  • Create, review and approve quality documents and test data.
  • Manage validation, exception event and change control processes.
  • Maintain tracking of validation equipment, if applicable.
  • Complete all required training before executing a task.
  • Document all activities in line with cGMP requirements.
Requirements:
  • Qualification in an engineering or scientific discipline.
  • Extensive experience in medical device plastics processing, moulding or assembly operations.
  • Strong knowledge of cGMP and regulatory requirements relating to the medical device industry.
  • Excellent communication, presentation and troubleshooting skills.
  • Effective interpersonal and organisational skills.
  • Ability to work well independently and as part of a team.
Benefits:

This role offers opportunities for personal and professional growth in a state-of-the-art pharmaceutical facility.

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