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QA Validation Specialist

1 month ago

Dublin, Dublin City, Ireland LSC, Life Science Consultants Full time
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About the Project - Key Responsibilities:
  • Lead, facilitate, and participate in 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 implementation of appropriate actions.
  • Engage in all project phases, including conceptual design, equipment procurement, construction, installation, startup, qualification, and system release.
  • Review and approve Change Controls, Deviations/CAPAs, SOPs, and related documentation to ensure GMP compliance.
  • Provide QA oversight for qualification/validation, technical transfers, regulatory approvals, and operations.
  • Review and approve validation lifecycle documents and reports.
About You - Are Your Skills a Match?
  • A postgraduate qualification in engineering or science (Science/Quality/Technical) is advantageous.
  • Minimum of 5 years' experience in Quality Assurance or Validation within the biological or pharmaceutical industry, especially in computer systems validation, engineering, or IT/OT functions.
  • Experience in commissioning and qualification/validation of computerized systems and process equipment (e.g., bioreactors, chromatography, autoclaves).
  • Knowledge of GAMP requirements related to computer system qualification and validation is a plus.

Note: Applicants must possess a Stamp 1G or Stamp 4 visa for contracting positions in Ireland's pharmaceutical industry. Visa sponsorship is not available.

Apply via this advert or contact Sarina Abdulha at 021 4777 329 for more information.

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