QA Specialist – Carlow

PE Global (UK); Carlow; On-site; EUR 40,000 - 55,000; Full time

Job summary

A multinational pharmaceutical company is seeking a QA Specialist in Carlow for an 11-month contract role with a 4-shift pattern. The ideal candidate will have a Bachelor's degree in a Science discipline, along with 1-2 years of quality experience in pharmaceutical manufacturing, especially in sterile environments. Responsibilities include reviewing batch documentation, supporting production teams, and ensuring compliance with quality standards. Interested candidates should apply by sending an updated CV.

Qualifications

• 1-2 years experience in a Quality Role at pharmaceutical manufacturing facility.
• Experience in aseptic manufacturing preferred.
• Knowledge of cGMP and GDP essential.

Responsibilities

• Conduct timely reviews of batch documentation and investigations.
• Support the spot check/walk-through process of the production lines.
• Respond quickly to unplanned events and technical issues.

Skills

Technical knowledge of sterile manufacturing processes

Ability to learn and utilize computerized systems

Prioritization and multitasking

Education

Bachelor's Degree in a Science discipline

Tools

SAP

Trackwise

MES

Job description

JOB DESCRIPTION & SPECIFIC OBJECTIVES

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

11-month initial contract- with 33% Shift Premium – 4 cycle shift pattern, 12 hours day/nights

• 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
• 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

Typical Minimum Education

• Bachelor’s Degree or higher preferred in a Science discipline

Typical Minimum Experience

• 1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing
• Experience in SAP, MES, Trackwise desirable

Technical

• 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

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV [e-mail]

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