GMP Compliance & Quality Assurance Specialist

Servier Ireland; Arklow; On-site; EUR 50,000 - 80,000; Full time

Benefits offered by this job

Tailor-made onboarding

Mobility opportunities

Quality trainings

Professional development

Job summary

Servier Ireland in Arklow, Co. Wicklow, is seeking a QA Compliance Specialist reporting to the QA Compliance manager. The role focuses on supplier and outsourced activity management, audits, CAPAs, and recalls to ensure GMP compliance.

You will contribute to the Pharmaceutical Quality System, support regulatory inspections, draft procedures, and deliver GMP training. The ideal candidate has 2+ years in pharma or 5+ years in quality, strong writing and communication skills, and a detail‑driven,

Qualifications

• 2+ years’ experience in the Pharmaceutical Industry and a 3rd level qualification in a scientific discipline.
• Strong communication, interpersonal and organisational skills.
• Strong IT skills.
• Excellent writing skills.
• Strong attention to detail and decision-making skills.

Responsibilities

• Ensure the effective implementation and continuous improvement of the Pharmaceutical Quality System (PQS) and maintain regulatory compliance.
• Provide complaint data for Product Quality Reviews (PQRs) and Continued Process Verification (CPV) activities.
• Participate in regulatory inspections and supplier audits; support CAPA programs.
• Draft, review and approve written procedures and documents (SOPs, WISOPs, Quality Policy).
• Coordinate Quality Defect Reports and recalls; support mock recalls as required.
• Lead internal audits, self-inspections and VCQ activities; ensure timely corrective actions.
• Deliver routine GMP training on site and participate in site quality projects.

Skills

Communication skills

Interpersonal skills

Organisational skills

IT skills

Writing skills

Attention to detail

Education

Third level qualification in a scientific discipline

Job description

Servier Ireland in Arklow, Co. Wicklow, is seeking a QA Compliance Specialist reporting to the QA Compliance manager. The role focuses on supplier and outsourced activity management, audits, CAPAs, and recalls to ensure GMP compliance.

You will contribute to the Pharmaceutical Quality System, support regulatory inspections, draft procedures, and deliver GMP training. The ideal candidate has 2+ years in pharma or 5+ years in quality, strong writing and communication skills, and a detail‑driven,