Operations Compliance Officer

The Operations Compliance Officer supports the Operations function in maintaining GMP compliance across day-to-day manufacturing and site activities. Working closely with Operations, QA and Regulatory Affairs, the role identifies, investigates and helps resolve compliance gaps, ensuring that issues are addressed promptly and effectively before they become recurring problems or audit findings

This is a hands-on, floor-facing role suited to someone comfortable moving between production areas and documentation review, who can translate regulatory requirements into practical, workable procedures for operators and supervisors.

Key Responsibilities

Production & operations compliance

Monitor production floor activities against approved SOPs, batch records, and GMP requirements; flag deviations at source.

Lead or support TCC and NCR investigations, including root cause analysis, identification of appropriate corrective actions and effectiveness checks.

Review and support the updating of SOPs, work instructions and batch documentation in response to process, equipment, regulatory or GMP changes.

Support change control for production and equipment changes, assessing compliance impact before implementation.

Track and report compliance-related production metrics (deviation rates, right-first-time, overdue actions) to Operations and QA leadership.

GMP/QA compliance & audits

Support preparation for and follow-up of internal and external audits and inspections, including tracking actions, gathering objective evidence and supporting timely responses to findings.

Support CAPA management: logging, root cause analysis, implementation tracking, and closure with objective evidence.

Conduct routine self-inspections and floor walks to identify compliance risks ahead of formal audits.

Conduct and support data integrity reviews of paper and electronic records, applying ALCOA+ principles and identifying potential gaps or risks.

Maintain audit and inspection readiness, documentation and contribute to responses to regulatory findings.

Knowledge & skills

Working knowledge of EU GMP (EudraLex Volume 4), ICH Q10, and HPRA guidance.

Strong root cause analysis and technical writing skills (investigations, CAPA, SOPs).

Familiarity with data integrity principles (ALCOA+) across paper and electronic systems.

Clear communicator with the ability to work effectively across Operations, QA, Regulatory Affairs and other relevant support functions.

Organised, detail-oriented, and able to manage multiple open investigations or audits at once.

Pay: €35,000.00-€38,000.00 per year

Benefits

Company pension

* On-site parking

Work Location: In person