Biopharmaceutical Data Specialist

2 days ago

Galway, Galway, Ireland beBeeData Full time €60,000 - €120,000

Quality Assurance Specialist

This role involves ensuring the quality and integrity of digital data across a biopharmaceutical site. As a key member of the Quality Assurance team, you will be responsible for overseeing validation and digital data activities, reviewing and approving GMP documentation, and supporting cross-functional teams.

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

Requirements:

  • 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)

Why Join Our Team?

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

Apply Now:

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