QA Specialist

Recruitment by Aphex; Carlow; On-site; EUR 40,000 - 55,000; Full time

Job summary

A leading pharmaceutical firm in Carlow is seeking a Quality Assurance Specialist to ensure compliance and product safety in a sterile manufacturing environment. You will conduct batch reviews, respond to events, and support continuous improvement initiatives. The ideal candidate holds a Bachelor's degree in a Science discipline and has 1-2 years of experience in a quality role, preferably with knowledge of cGMP. This position requires strong problem-solving skills and the ability to work in a fast-paced setting.

Qualifications

• Minimum of 1-2 years of experience in a Quality role within a pharmaceutical environment.
• Demonstrated operational experience with quality systems is essential.
• Working knowledge of regulatory requirements for sterile products.

Responsibilities

• Perform reviews of batch documentation and ensure compliance.
• Support investigations and ensure effective CAPAs are implemented.
• Provide daily Quality support to production teams.

Skills

Strong technical knowledge of sterile manufacturing processes

Excellent communication skills

Problem-solving skills

Experience with quality systems like SAP and Trackwise

Education

Bachelor’s Degree in a Science discipline

Tools

Microsoft Office

Trackwise

SAP

Job description

Purpose

The Quality Assurance Specialist is a vital partner to our Integrated Production Team (IPT), ensuring the highest standards of quality and compliance are met in our sterile manufacturing facility. Your primary purpose is to safeguard product quality and patient safety by providing real-time quality oversight, reviewing critical processes, and fostering a culture of continuous improvement and cGMP excellence. You will be the on-the-ground quality expert, responding to events and ensuring our operations are always audit-ready.

Shift Pattern: 4-shift pattern - 12 hours per shift. Week 1 long week: Monday - Tuesday Days then Fri, Sat, Sun nights. Week 2 short week: Wed and Thurs Days. Week 3 long week: Monday - Tuesday nights, Fri, Sat, and Sun days. Week 4 short week: Wed and Thurs nights.

Responsibilities

• Perform timely and detailed reviews of batch documentation, including Electronic Batch Records (EBRs), line clearances, and associated reports.
• Identify, highlight, and assist in the resolution of quality concerns, ensuring actions are commensurate with risk.
• Support the spot check and walk-through process of the production lines to verify adherence to cGMP.
• Respond quickly to unplanned events and technical issues, providing immediate quality guidance.
• Support and review investigations, including customer complaints, to ensure root causes are identified and effective CAPAs are implemented.
• Utilize quality systems (e.g., Trackwise, SAP, MES) for managing deviations, CAPAs, and change controls.
• Conduct, report, and display Quality Right-First-Time and audit readiness metrics weekly to drive continuous compliance.
• Liaise with department representatives to promote improvements in GMP and quality standards.
• Provide daily Quality support to IPT production teams, acting as a subject matter expert on quality matters.
• Ensure compliance with our Company's Manufacturing Division, Quality, and EHS (Environment, Health, and Safety) Management System requirements.

Requirements

• Bachelor’s Degree or higher in a Science discipline (Microbiology, Chemistry, Pharmacy, or related field) is preferred.
• Minimum of 1-2 years of experience in a Quality role within a pharmaceutical manufacturing facility; experience in aseptic/sterile manufacturing is highly preferred.
• Demonstrated operational experience with quality systems such as SAP, Trackwise, and MES (Manufacturing Execution System).
• Essential: Strong technical knowledge of sterile manufacturing processes and a full understanding of cGMP and GDP principles.
• Essential: Working knowledge of Irish, EU, and US regulatory requirements for sterile products.
• Proven ability to prioritize multiple tasks, manage deadlines, and work effectively in a dynamic, fast-paced environment.
• Strong problem-solving skills with the ability to make risk-based decisions.
• Excellent communication and report-writing skills.
• Competent in the use of Microsoft Office applications.