Job Title

QC Instrumentation Specialist

Overview

The QC Instrumentation Specialist supports Quality Control (QC) Quality Systems and provides technical expertise to ensure laboratory instrumentation and computerized systems remain compliant with regulatory and data integrity requirements. This role reports to the QC Manager and acts as a subject matter expert (SME) across QC instrumentation and systems.

Location

• Onsite role based in Galway

• 5 days per week

Key Responsibilities

QC Systems & Instrumentation

• Qualification, maintenance, and integration of QC systems in compliance with current data integrity, regulatory, and industry standards.

• Ensure Computer System Validation (CSV) procedures are implemented for all QC laboratory systems.

• Manage change control processes to maintain continued compliance of QC systems and instrumentation.

• Ensure data integrity requirements are defined and met during new instrument qualification.

Compliance, Investigations & Audits

• Act as SME for troubleshooting, investigations, deviations, and non-conformances within QC.

• Manage deviations, CAPAs, and change controls in line with QC priorities.

• Support OOS, OOT, deviations, and change control investigations as required.

• Represent QC during internal and external audits and regulatory inspections; follow up on resulting corrective actions.

• Maintain the QC laboratories in a constant state of audit readiness.

Documentation & Validation

• Prepare and review validation documentation including protocols, reports, risk assessments, SOPs, and trend reports.

• Establish and maintain procedures for validated systems (e.g. security, data archiving, project creation).

• Ensure laboratory documentation, logbooks, notebooks, and records are maintained to GLP/GMP standards.

• Ensure all QC records are current, accurate, and appropriately filed.

Equipment & Vendor Management

• Maintain and update the QC laboratory equipment inventory.

• Coordinate with vendors, calibration providers, EHS, QA, and QC to deliver qualification and re-qualification schedules.

• Support management of service and calibration contracts for QC instrumentation.

• Review calibration and maintenance records in line with approved procedures.

Cross-Functional & Continuous Improvement

• Participate in cross-functional teams to support QC instrumentation and validation activities.

• Engage proactively with stakeholders to understand requirements and escalate issues where necessary.

• Support continuous improvement initiatives including 5S, standard work, and new projects.

• Drive improvements across QC laboratory processes and systems.

Laboratory Operations & Safety

• Ensure compliance with cGMP, site policies, procedures, and regulatory requirements.

• Support good housekeeping, hygiene, and laboratory safety standards at all times.

• Identify and escalate safety, compliance, or operational issues to management.

Technical Expertise

• Demonstrate technical competency in HPLC, IR, UV, dissolution, and physical testing techniques.

• Provide timely, accurate technical input to support QC investigations and laboratory activities.

• Ensure effective and timely communication of queries and issues.

Education & Experience

• Bachelor’s degree in a science-based discipline (or equivalent).

• Minimum 5 years’ experience in a pharmaceutical or regulated laboratory environment.

• Experience working in a cGLP environment with knowledge of EU GMP and US FDA guidelines.

• Strong computer skills, including Microsoft Word and Excel.

Skills & Competencies

• Proven experience with URS, IQ, OQ, equipment validation, and laboratory instrumentation.

• Strong knowledge of change control, deviations, CAPA, SOPs, and analytical test methods.

• High awareness of data integrity principles (ALCOA++).

• Strong communication skills (written and verbal).

• Ability to build effective relationships and collaborate cross-functionally.

• Ethical, professional, and confident in escalating issues appropriately.

• Methodical, organised, and structured approach to work.

• Proactive, flexible, and willing to develop and expand technical expertise.

• Experience updating controlled documentation and technical reports.