Are you passionate about Quality Assurance in a fast-paced cGMP manufacturing environment?
We are seeking a Quality Assurance Specialist to join a leading biopharmaceutical company at their state-of-the-art Carlow facility.
This role is essential in ensuring compliance with regulatory standards while supporting manufacturing operations to deliver high-quality drug products
About the Role:
This is a shift-based role within the Integrated Production Team (IPT), providing real-time quality oversight and ensuring compliance with cGMP and regulatory requirements.
Key responsibilities include:
Key Responsibilities:Batch Documentation & Compliance: Review and approve manufacturing batch documentation, including electronic batch records, SOPs, and cleaning validation reports
Quality Oversight:
Provide on-the-floor support, ensuring compliance in manufacturing operations, area clearances, and batch record reviews
Deviation & Change Control Management:
Collaborate with Quality Specialists and QA Leads to resolve queries and drive compliance initiatives
GMP Training & Implementation:
Support the training of teams on Quality Management Systems and regulatory compliance
Continuous Improvement:
Drive improvements through quality reporting measures, self-inspection programs, and compliance initiatives
Cross-Functional Collaboration:
Work with teams across Production, Microbiology, Utilities, and Maintenance to ensure quality and regulatory adherence
Regulatory Audits & Inspections:
Participate in audits, inspections, and plant-wide GMP initiatives
What You Need to Succeed:
Degree qualified in Science, Technical, or a related discipline.
Experience in quality assurance within a pharmaceutical manufacturing environment.
Strong knowledge of US & European cGMP guidelines and regulatory requirements.
Experience in GMP audits, deviation management, and quality systems.
Ability to analyze trends, solve problems, and make risk-based quality decisions.
Excellent communication, people management, and project management skills.
A strong advocate for continuous improvement and innovation in quality compliance.
Why Join?Opportunity to work in a cutting-edge biopharmaceutical facility.
Collaborative and innovative work environment.
Career progression opportunities in a globally recognized company.
Competitive salary and benefits package.
If you are a quality-driven professional looking to make an impact in pharmaceutical manufacturing, apply now or reach out for a confidential discussion.
The Next Step for YouShould this position be of interest, please apply through LinkedIn with an up-to-date CV to Jessica from Next Generation Recruitment or call us on the main line at Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical, and Operation positions (permanent, contract, and temporary).
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