QC Compliance Lead - GMP, CAPA & Data Integrity

Uniting Holding; Ireland; On-site; EUR 60,000 - 80,000; Full time

Job summary

Uniting Holding is seeking a QC Compliance Officer to ensure all QC laboratory activities meet EU GMP, FDA, ICH and internal standards. You will oversee CAPAs, investigations, and data integrity while supporting audits and regulatory inspections. The role is onsite in Loughrea, Ireland, working with QC, QA and cross-functional teams.

The candidate will review SOPs, support method validation, and manage change controls and documentation to sustain compliance and continuous improvement.

Qualifications

• Bachelor’s degree in a science-based discipline.
• 3+ years working in a pharmaceutical cGLP environment.

Responsibilities

• Write, review, and update SOPs in line with regulatory requirements.
• Prepare test procedures for finished product and raw materials.
• Support analytical testing methods (HPLC, IR, UV, dissolution, physical testing).
• Review QC documentation for compliance with pharmacopoeias and regulatory standards.
• Prepare method transfer protocols and reports.
• Investigate OOS and OOT, manage CAPAs and deviations.
• Oversee calibration and maintenance of laboratory equipment; ensure GLP compliance.
• Maintain GMP/GLP documentation, logs, and notebooks per standards.
• Collaborate with QC, QA, and production to ensure timely reporting and issue resolution.
• Assist with audits and regulatory inspections; support continuous improvement initiatives.

Skills

Communication

Data integrity

Attention to detail

Collaboration

Organized

Education

Bachelor’s degree in science

Job description

Uniting Holding is seeking a QC Compliance Officer to ensure all QC laboratory activities meet EU GMP, FDA, ICH and internal standards. You will oversee CAPAs, investigations, and data integrity while supporting audits and regulatory inspections. The role is onsite in Loughrea, Ireland, working with QC, QA and cross-functional teams.

The candidate will review SOPs, support method validation, and manage change controls and documentation to sustain compliance and continuous improvement.