Quality Control Specialist

3 weeks ago


Galway, Galway, Ireland Steripack Full time

Quality Control Specialist

Our Client is seeking an experienced QAV / DDQ Specialist to join the Quality Assurance team at their facility in Co. Meath, where you'll play a key role in maintaining digital data quality and validation compliance across a state-of-the-art biopharmaceutical site. This position offers the opportunity to lead and support quality oversight for validation, computer systems, and regulatory compliance in line with cGMP, FDA, and EMEA standards.

Key Responsibilities:

  • Provide QA oversight for validation and digital data activities (CSV, equipment, and process systems)

  • Review and approve GMP documentation (Change Controls, Deviations, CAPAs, SOPs)

  • Support cross-functional teams and lead risk assessments

  • Drive continuous improvement and audit readiness

  • Interpret evolving regulatory guidance and update quality systems accordingly

Ideal Candidate:

  • 5+ years' QA/Validation experience in pharma/biotech (CSV experience essential)

  • Strong knowledge of GAMP, cGMP, and regulatory agency requirements

  • Proficient in systems like Veeva Vault, SAP, Trackwise, and KNEAT

  • Excellent communication and problem-solving skills

  • Relevant degree in science, engineering, or a related field (postgraduate preferred)

This is a fantastic opportunity to contribute to a forward-thinking, compliance-focused QA team in a globally respected organization.

Apply now to be part of a world-class team shaping the future of biopharma quality, email your CV to

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