Quality Assurance Specialist for Equipment Validation

11 hours ago

Cork, Cork, Ireland beBeeQualityAssurance Full time €45,000 - €60,000

About the Role

We are seeking a Quality Assurance Specialist to join our team and provide quality oversight for equipment validation activities.

Job Summary

This role involves establishing site validation policies, reviewing and approving project lifecycle documentation, and maintaining current knowledge of industry standards and regulatory requirements.

Key Responsibilities:

  • Provide quality oversight for FUE activities related to our products and facilities
  • Support the development of validation plans for specific system implementation projects
  • Review and approve project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)
  • Establish Site Validation Policies through the development, generation, and implementation of validation master plans, guideline documents, and SOPs
  • Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by us
  • Lead and represent QA Validation in multi-departmental meetings & project teams
  • Identify and implement improvements to the QA Validation systems
  • Participate in the change control program for modifications to qualified systems
  • Quality oversight for the Revalidation Evaluation program
  • Identify, track, and resolve issues through robust root cause analysis in a timely manner working with relevant SMEs as required

Requirements

To be successful in this role, you will need:

  • Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required
  • +3 years' experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems/validation
  • Organizational and management skills to coordinate multi-discipline project groups
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations
  • Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations
  • Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred

What We Offer

We offer a competitive salary, comprehensive benefits package, and opportunities for career growth and professional development. Our work-life balance programs help you recharge and refocus, while our inclusive culture celebrates diversity and promotes collaboration.

Contact Us

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