Job Description Your New Job Our client, a leading global pharmaceutical company, is currently seeking a Quality Assurance (QA) Specialist to join their team on a contract basis at their state-of-the-art manufacturing site in Carlow.
This is an excellent opportunity to work in a high-performing, fast-paced sterile manufacturing environment supporting production teams across a 4-shift cycle.
As QA Specialist, you will be responsible for providing quality oversight and ensuring compliance with GMP standards.
The role will involve review of batch documentation, supporting investigations, and working cross-functionally with manufacturing and quality systems teams.
This role is ideal for someone who has strong attention to detail, a passion for quality, and is looking to grow their experience within a dynamic pharmaceutical setting.
Key Duties & Responsibilities Provide day-to-day quality support to production teams, ensuring compliance with GMP standards and site procedures.
Perform timely review and approval of batch documentation (EBRs), including line clearance verification.
Assist in investigations of deviations, customer complaints, and unplanned events, using systems such as Track Wise.
Conduct and report on routine audit readiness and quality metrics to drive continuous improvement and maintain compliance.
Participate in spot-checks and walkthroughs on the production floor to monitor adherence to quality standards.
Ensure compliance with current GMP, FDA, EMA, and internal quality standards and regulations.
Liaise with cross-functional teams (Manufacturing, Engineering, QC) to identify and implement quality improvements.
Utilize computerized systems (SAP, MES) for recording, tracking, and reporting quality-related activities.
Maintain awareness of industry trends and regulatory updates relevant to sterile manufacturing.
What Are We Looking For? Bachelors degree (or higher) in a Science or related discipline.
12 years experience in a QA role within a pharmaceutical manufacturing environment, ideally with aseptic/sterile processing exposure.
Strong working knowledge of c GMP and GDP.
Experience using quality systems such as SAP, MES, and Track Wise is desirable.
Ability to prioritise and manage multiple tasks in a fast-paced setting.
Strong interpersonal and communication skills.
A proactive mindset with a focus on audit readiness and continuous improvement.
Why This Job? Join a world-renowned pharmaceutical leader with a strong reputation for innovation and quality.
Gain valuable experience in a sterile manufacturing environment working on a 4-cycle shift pattern.
Be part of a collaborative team environment with opportunities to develop professionally.
Competitive hourly rate and contract benefits available.
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Skills: Trackwise c GMP GMP QMS