Quality Assurance Manager

2 weeks ago

Dunboyne, Meath, Ireland beBeeQuality Full time €60,000 - €96,000
Quality Assurance Specialist

We are seeking a skilled Quality Assurance Specialist to join our team. As a key member of the quality assurance team, you will have quality oversight of digital data quality and validation activities at the client facility.

  • Key Responsibilities:
  • Lead, facilitate, and participate in daily cross-functional teams to address compliance issues and achieve project milestones.
  • Participate in investigations and risk assessments related to deviations, complaints, and changes, ensuring timely actions are implemented.
  • Collaborate on project teams through all phases, from conceptual design to system release.
  • Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs, and related documentation for compliance to GMP and site requirements.
  • Ensure quality oversight of qualification/validation, technical transfers, regulatory approvals, and commercial/clinical operations.
  • Review and approve validation lifecycle documents and reports.
  • Evaluate new and prospective regulatory guidance and industry best practices, identifying and implementing updates as required.
Requirements:
  • Postgraduate qualification in an engineering or science discipline is advantageous.
  • Minimum 5 years' experience in Quality Assurance/Validation within the Biological and/or pharmaceutical industry.
  • Experience in commissioning and qualification/validation of computerized systems and process equipment.
  • Knowledge of GAMP requirements is a distinct advantage.
  • Strong written and verbal communication skills, with the ability to think logically and be proactive under pressure.
  • Demonstrated experience in QRM, Investigations, Problem-solving as a Quality SME.

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