QC Compliance Officer

Overview

The Quality Control (QC) Compliance Officer ensures full adherence of all QC laboratory operations to applicable regulatory standards such as EU GMP, FDA, and ICH, along with internal quality protocols. This role plays a vital part in maintaining and enhancing the QC quality management system through oversight of investigations, CAPA management, compliance documentation review with a data integrity focus, and guaranteeing prompt resolution of quality events.

Collaborating with departments including QC, QA, and others, the officer supports readiness for audits and regulatory inspections, participates in risk evaluations and change control procedures, and drives continuous improvement efforts.

This position is based onsite at the client facility located in Loughrea, County Galway, Ireland.

Key Responsibilities

• Authoring, revising, and maintaining Standard Operating Procedures (SOPs).
• Developing procedures for finished product and raw material testing.
• Demonstrating competency and support in analytical methods such as HPLC, IR, UV spectroscopy, dissolution, and various physical tests.
• Reviewing QC lab documentation to confirm compliance with pharmacopoeial standards, specifications, regulatory mandates, and industry best practices.
• Preparing and evaluating analytical method transfer protocols and related reports.
• Managing Out of Specification (OOS) and Out of Trend (OOT) investigation documentation and processes.
• Administering Change Controls, CAPAs, and Deviation workflows to ensure timely handling and closure.
• Overseeing calibration and upkeep of laboratory equipment to assure operational readiness.
• Controlling issuance and documentation of laboratory logbooks and notebooks per Good Laboratory Practice (GLP) standards.
• Collaborating with team leaders, supervisors, and production units to ensure results reporting and issue resolution are timely and effective.
• Responding promptly to quality and compliance questions.
• Escalating any discrepancies or non-conformances identified during laboratory work.
• Supporting corrective action implementation and follow-up activities.
• Participating actively in both internal and external audit processes.
• Promoting adherence to quality procedures and fostering continuous process improvements through change control initiatives.
• Maintaining high laboratory standards for housekeeping, hygiene, and safety.
• Ensuring all laboratory processes comply with GLP and GMP regulations.
• Maintaining accurate QC records and systematically filing documentation.
• Utilizing Microsoft Office tools and specialized quality management software to support compliance functions.
• Performing additional compliance-related responsibilities as assigned.

Qualifications and Experience

• A bachelor's degree in a scientific discipline.
• At least three years of relevant experience in a pharmaceutical cGLP environment.
• Familiarity with pharmaceutical quality standards, including EU GMP and US FDA regulations.
• Proficient computer skills, particularly with Microsoft Office applications.
• Experience with quality investigations, CAPAs, deviation management, and quality systems is advantageous.
• Audit participation and regulatory compliance experience is desirable.

Competencies and Attributes

• Strong interpersonal skills fostering collaboration throughout diverse teams.
• Effective verbal and written communication capabilities.
• Committed to ethical conduct and unwavering compliance principles.
• Adaptability and willingness to continually expand technical knowledge and expertise.
• Methodical, organized, and structured in approach to tasks.
• Keen attention to detail emphasizing data integrity.
• Ability to prioritize tasks, distinguishing urgent versus non-urgent matters.
• Proactive, positive mindset demonstrating personal accountability and ownership.
• Capability to escalate issues appropriately and drive continuous improvement.

Equal Opportunity and Inclusion

Candidates from diverse backgrounds, including those returning to the workforce or bringing transferable skills from unconventional career paths, are strongly encouraged to apply. The organization values diverse experiences and is dedicated to creating an inclusive environment that supports individuals with disabilities.