QC Compliance Officer

About the role

The QC Compliance Officer ensures that all Quality Control laboratory activities meet EU GMP, FDA, ICH and internal quality standards. Working on‑site in Loughrea, you will collaborate with QC, QA and cross‑functional teams to maintain audit readiness and drive continuous improvement.

Key responsibilities

• Write, review and update Standard Operating Procedures (SOPs).
• Prepare test procedures for finished products and raw materials.
• Demonstrate competency in analytical techniques such as HPLC, IR, UV, dissolution and physical testing.
• Review QC documentation for compliance with pharmacopoeias, specifications and regulatory requirements.
• Prepare analytical method transfer protocols and reports.
• Lead Out‑of‑Specification (OOS) and Out‑of‑Trend (OOT) investigations.
• Manage Change Controls, CAPAs and Deviations to ensure timely progression and closure.
• Oversee calibration and maintenance of laboratory equipment.
• Control laboratory logbooks, notebooks and GLP documentation.
• Liaise with team leaders, supervisors and production to report results and resolve issues.
• Participate in internal and external audits and support corrective‑action implementation.
• Maintain laboratory housekeeping, hygiene and safety in line with GLP/GMP.

Required profile

• Bachelor’s degree in a science‑based discipline.
• Minimum 3 years experience in a pharmaceutical cGLP environment.
• Strong knowledge of EU GMP and US FDA guidelines.
• Proven experience supporting investigations, change control and CAPA processes.
• Excellent computer skills, particularly Microsoft Office.

Required skills

• Analytical techniques: HPLC, IR, UV, dissolution, physical testing.
• Method transfer and documentation preparation.
• OOS/OOT investigation and root‑cause analysis.
• Change control, CAPA and deviation management.
• Calibration, equipment maintenance and GLP/GMP compliance.
• Use of quality management systems and Microsoft Office applications.