QA Technician – Shift

PE Global (UK); Carlow; On-site; EUR 35,000 - 50,000; Full time

Job summary

PE Global is recruiting a QA Technician for a client in Carlow. This 11-month initial contract involves a 4-shift pattern (12-hour shifts) across days and nights, supporting cGMP quality systems and sterile manufacturing processes.

The role requires a science degree and 1–2 years in a pharmaceutical QA/quality role, with experience in SAP, MES or Trackwise; you will review batch documentation, assist investigations, and ensure audit readiness while working cross-functionally to uphold quality

Qualifications

• Bachelor’s degree in a science discipline preferred.
• 1–2 years’ experience in a quality role within pharmaceutical manufacturing (aseptic preferred).
• Experience with SAP, MES or Trackwise desirable.
• Working knowledge of Irish, European and international GMP standards.
• Proficient in GMP/GDP documentation and policy writing.

Responsibilities

• Provide QA support to IPT production teams to maintain cGMP standards.
• Learns and utilizes computerized systems for daily tasks.
• Prioritize multiple tasks, manage deadlines, and support batch documentation reviews.
• Assist in investigations, line clearances, and audit readiness.
• Participate in cross-functional teamwork to improve GMP and quality systems.

Skills

Quality Assurance

GMP knowledge

Regulatory compliance

Documentation

Education

Bachelor's Degree in Science

Tools

SAP

MES

Trackwise

Job description

PE Global is currently recruiting a QA Technician on behalf of our client based in Carlow:

11-month initial contract- Shift

The Quality Assurance Specialist within Our Company is required to

• Work a 4 shift pattern role
• Technical knowledge of sterile manufacturing processes
• Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk
• Respond quickly to unplanned events, technical issues
• Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES
• Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements
• Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
• Support the spot check/walk-through process of the production lines
• Involved in customer complaint investigation if required
• Work well cross functionally and be an active team member

POSITION RESPONSIBILITIES

• Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
• Understanding of sterile manufacturing operations is preferred.
• Ability to learn and utilize computerized systems for daily performance of tasks.
• Ability to prioritize, manage multiple tasks, and meet deadlines.
• Perform timely reviews on batch documentation ( EBR’s ) / line clearances/ assist in the resolution of concerns commensurate with the risk. Liaise with other Department representatives to promote improvements in GMP and Quality standards
• Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.

QUALIFICATIONS & EXPERIENCE – KNOWLEDGE AND SKILLS REQUIREMENTS

• Bachelor’s Degree or higher preferred in a Science discipline
• 1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing
• Experience in SAP, MES, Trackwise desirable
• Working knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Knowledge of cGMP and GDP essential Report, standards, policy writing skills required
• Competent in the use of MES and SAP

This is a shift position – 4 cycle 12 hours per shift e.g Week 1- long week: Monday – Tuesday Days, Friday, Sat, Sun nights Week 2- short week: Wed and Thurs Days, Week 3:Long week: Monday – Tuesday nights, Friday, Sat and Sun Days Week 4: short week: Wednes and Thurs Nights

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***