Quality & Compliance Specialist (QA Operations)

Biopharma Careers

Dublin

À distance

EUR 42 000 - 62 000

Plein temps

Il y a 3 jours
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Résumé du poste

Biopharma Careers is seeking a QA Operations professional (PSCI) to help ensure compliance with MAH, MIA, WDA, ASR, GDP and GDP-related requirements across Perrigo Supply Chain International DAC and affiliates.

The role supports the QA team in day-to-day activities to maintain and enhance the Quality Management System, including documentation management, revisions to maps and SOPs, supplier/customer qualification, and participation in audits and regulatory inspections.

Qualifications

  • Experience using standard business applications (Microsoft Office Suite).
  • Training on internal processes and procedures.
  • Industry experience not essential.
  • Pursuing third level education.

Responsabilités

  • Revise and upload PSCI supply chain maps to reference the PSCI entity.
  • Revise Standard Operating Procedures and Work Instructions to reference the PSCI entity.
  • Manage documentation including archiving, SharePoint management, and filing.
  • Support the raising of deviations, distribution complaints, temperature excursions, and CAPAs as required.
  • Assist with revisions to approved product, supplier, and customer listings.
  • Assist in supplier and customer/affiliate qualification and maintenance.
  • Perform independent verification checks of licences (e.g., EUDRA, MHRA, HPRA, FAGG).
  • Participate in self-inspections, internal and regulatory audits, and ensure corrective actions are implemented.
  • Be flexible to take on additional tasks as directed by the Manager.
  • Assist in the effective implementation and continuous improvement of the Quality Management System.

Connaissances

Microsoft Office Suite

Formation

Pursuing third level education

Description du poste

Biopharma Careers is seeking a QA Operations professional (PSCI) to help ensure compliance with MAH, MIA, WDA, ASR, GDP and GDP-related requirements across Perrigo Supply Chain International DAC and affiliates.

The role supports the QA team in day-to-day activities to maintain and enhance the Quality Management System, including documentation management, revisions to maps and SOPs, supplier/customer qualification, and participation in audits and regulatory inspections.

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