Hybrid QA Systems & Compliance Specialist (cGxP/eQMS)

Astellas; Ireland; Ibrido; EUR 40.000 - 55.000; Tempo pieno

Descrizione del lavoro

Astellas is seeking a QA professional to support cGxP compliance at its Killorglin, Kerry facility. The six-month FTC involves quality systems, audits, and product quality reviews. You will review eQMS records, coordinate internal and external audits, and drive continuous improvement through lean initiatives.

A background in pharmaceutical quality, cGMP, and good documentation practices is preferred. This hybrid role offers collaboration across QA teams and external partners, contributing to

Competenze

• BSc or equivalent academic qualification required.
• Industrial/pharmaceutical experience preferred.
• Familiarity with cGMP, audits and eQMS workflows.
• Knowledge of GxP and regulatory submissions.

Mansioni

• QA review & approval of eQMS records and related documents.
• Support TrackWise metrics and QMS progression with stakeholders.
• Coordinate internal and external audits and ensure CAPA follow-up.
• Assist in regulatory updates and GMP trends.
• Contribute to Product Quality Reviews and LEAN initiatives.

Conoscenze

cGMP

Auditing

Customer complaint investigations

eQMS support

Good Documentation Practices

5S

Regulatory updates

Formazione

BSc or equivalent

Descrizione del lavoro

Astellas is seeking a QA professional to support cGxP compliance at its Killorglin, Kerry facility. The six-month FTC involves quality systems, audits, and product quality reviews. You will review eQMS records, coordinate internal and external audits, and drive continuous improvement through lean initiatives.

A background in pharmaceutical quality, cGMP, and good documentation practices is preferred. This hybrid role offers collaboration across QA teams and external partners, contributing to