The QC Compliance Officer is responsible for ensuring that all Quality Control laboratory activities comply with applicable regulatory requirements (e.g., EU GMP, FDA, ICH) and internal quality standards. The role supports the maintenance of a compliant QC quality system by overseeing investigations, managing CAPAs, reviewing documentation for data integrity (ALCOA+), and ensuring timely closure of quality events.
The position works closely with QC, QA, and other cross-functional departments to support audit readiness, regulatory inspections, and continuous improvement initiatives. The role also contributes to risk assessments, change control processes, and supports regulatory compliance activities where required.
Location: Onsite at our facility in Loughrea.
Write, review, and update Standard Operating Procedures (SOPs).
Prepare finished product and raw material test procedures.
Support and demonstrate competency in analytical techniques including HPLC, IR, UV, dissolution, and physical testing.
Review QC documentation to ensure adherence to pharmacopoeias, specifications, regulatory requirements, and industry standards.
Prepare analytical method transfer protocols and reports.
Prepare and review Out of Specification (OOS) and Out of Trend (OOT) investigations.
Prepare and manage Change Controls, CAPAs, and Deviations, ensuring timely progression and closure.
Review calibration and maintenance activities for laboratory equipment.
Manage the issuance and control of laboratory logbooks, notebooks, and associated documentation in accordance with GLP requirements.
Liaise with Team Leaders, Supervisors, and Production teams to ensure timely reporting of results and resolution of issues.
Ensure timely responses to quality and compliance queries.
Escalate discrepancies, deviations, and non-conformances identified within testing activities or laboratory practices.
Support the implementation and follow-up of corrective actions.
Participate in internal and external audits.
Ensure quality procedures are followed and support continuous improvement through change control and process enhancement initiatives.
Maintain high standards of laboratory housekeeping, hygiene, and safety.
Ensure laboratory activities remain compliant with GLP and GMP requirements.
Ensure QC records and documentation are maintained accurately and filed appropriately.
Utilize Microsoft Office applications and relevant quality systems to support compliance activities.
Support other compliance-related duties as assigned by the QC Team Leader, Supervisor, or Manager.
Qualifications and Experience:
Bachelor’s degree in a science-based discipline.
3+ years working in a similar role in a pharmaceutical cGLP environment
Experience working within a pharmaceutical cGLP environment with knowledge of EU GMP and US FDA guidelines.
Strong computer skills, including Microsoft Office applications.
Experience supporting investigations, CAPAs, deviations, and quality systems activities desirable.
Experience participating in audits and regulatory compliance activities desirable.
Skills and Competencies:
Ability to build effective working relationships and collaborate across teams.
Strong verbal and written communication skills.
High ethical standards with a strong compliance mindset.
Flexible and willing to continuously develop technical knowledge and skills.
Methodical, systematic, and structured approach to work.
Strong attention to detail and commitment to data integrity principles.
Ability to prioritise activities and differentiate between urgent and non-urgent matters.
Proactive and positive attitude with a strong sense of ownership and accountability.
Ability to appropriately escalate issues and support continuous improvement initiatives.
Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.
