QA Compliance Specialist: Drive GMP Excellence

Servier

Arklow

Remote

EUR 42,000 - 65,000

Full time

6 hours ago
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Job summary

Servier in Ireland is seeking a QA Compliance Specialist to oversee supplier and outsourced activity management, audits, inspections and CAPAs related to them, and to support recalls and GMP training.

The role focuses on maintaining the Pharmaceutical Quality System (PQS) in line with current regulatory requirements, with responsibilities across documentation, supplier approvals, audits, and continuous quality improvement on site.

Qualifications

  • 2+ years’ experience in the Pharmaceutical Industry or 5+ years in a quality function in pharma.
  • Strong communication, interpersonal and organisational skills.
  • Excellent writing skills.
  • Strong attention to detail and decision-making skills.

Responsibilities

  • Ensure effective implementation and continuous improvement of the PQS, maintaining regulatory compliance.
  • Provide complaint data for PQRs and CPV activities to support product and process performance monitoring.
  • Prepare and follow up on regulatory inspections and external audits of SII.
  • Draft, review and approve SOPs and other quality documents.

Skills

Quality Assurance
GMP Compliance
Audits & CAPAs
Documentation

Education

Bachelor’s degree in a scientific discipline

Job description

Servier in Ireland is seeking a QA Compliance Specialist to oversee supplier and outsourced activity management, audits, inspections and CAPAs related to them, and to support recalls and GMP training.

The role focuses on maintaining the Pharmaceutical Quality System (PQS) in line with current regulatory requirements, with responsibilities across documentation, supplier approvals, audits, and continuous quality improvement on site.

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