Compliance Specialist

Aphex Group; Carlow; On-site; EUR 42,000 - 65,000; Full time

Job summary

Aphex Group in Carlow is seeking an Engineering Compliance Specialist to support GMP and sterile manufacturing operations. The role focuses on review of deviation reports, CAPAs and engineering change controls to ensure timely documentation and regulatory compliance.

You will collaborate with IPT, Quality, EHS and other departments to uphold compliance, while following cGMP and global policies in daily tasks. Strong communication and relevant regulatory knowledge are essential.

Qualifications

• Diploma or higher in a related discipline preferred.
• Prior GMP manufacturing experience is advantageous.
• Excellent written and verbal communication with cross-functional teams.
• Familiarity with Irish, European and international regulatory expectations.

Responsibilities

• Direct and/lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis and implementing CAPAs.
• Supporting Engineering documentation review - e.g. electronic logs
• Supporting Audit Readiness activities.
• Supporting Internal Audit programs
• Collaborate with Engineering colleagues and other departments to maintain compliance
• Adhere to global policies, procedures and cGMP in daily activities.

Skills

GMP experience

Diploma/degree

Communication skills

Regulatory knowledge

Sterile filling experience

MS Office proficiency

Education

Diploma or higher in related discipline

Tools

Microsoft Office

Job description

Purpose

We are seeking an Engineering Compliance Specialist to join our Engineering Department at our Carlow site, supporting operations in a GMP and Sterile Environment. This role is essential for ensuring compliance, safety, and reliable product supply. Key responsibilities include generating and expediting the review of Manufacturing GMP documentation such as deviation reports (QNs) and corrective and preventative actions (CAPAs), leading Engineering change controls and supporting permanent inspection readiness. The Compliance Specialist will also author, edit, and review controlled documents, collaborate within cross-functional teams to solve problems using Root Cause Analysis (RCA) methodologies, and ensure timely completion of documentation to maintain compliance with regulatory requirements.

Responsibilities

• Direct and/lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective and preventative actions.
• Supporting Engineering documentation review - e.g. electronic logs
• Supporting Audit Readiness activities.
• Supporting Internal Audit programs
• Collaborate with Engineering colleagues and other departments particularly IPT, Quality, EHS, Technical Engineering in completion of tasks and maintaining compliance posture.
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned.

Requirements

• Diploma or higher preferred, ideally in a related discipline.
• Would typically have prior-related work experience; ideally in a manufacturing GMP setting.
• Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Sterile filling processes and equipment experience preferred.
• Proficiency in Microsoft Office and job-related computer applications
• Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers
• Understand the specific responsibilities of all Carlow departments as they relate to one's own department, understanding the business processes one's department supports
• Effective time management and multi-tasking skills