Job Description
Step Into a Hands-On Quality Role in Pharmaceutical Manufacturing
Quality Control Specialist (Associate Quality Specialist) - Ballydine, Co. Tipperary
Imagine being part of a team where every decision you make directly protects product quality, patient safety, and manufacturing excellence in a highly regulated pharmaceutical environment.
This opportunity sits within a fast-paced GMP manufacturing site in Ballydine, where science, compliance, and continuous improvement come together every day.
What you’ll achieve (and why it matters):
Bring your scientific knowledge and attention to detail into a role where quality and compliance are critical to every stage of production:
- Act as a key quality partner within a cross-functional Integrated Process Team supporting Right First Time manufacturing
- Review and approve batch records, cleaning records, and testing documentation to ensure GMP compliance
- Investigate and support Laboratory OOS results and process deviations, ensuring thorough documentation and CAPA alignment
- Support deviation investigations and carry out trending analysis to identify recurring issues and improvement opportunities
- Apply root cause analysis techniques to drive effective corrective and preventive actions
- Support change control processes from initiation through to completion, ensuring full compliance and documentation accuracy
- Contribute to risk assessments and support maintenance of validation status across processes and systems
- Prepare Annual Product and System Quality Reviews to support site quality performance monitoring
- Participate as lead auditor in GMP walkdowns and internal audit activities
- Support the generation, analysis, and communication of key quality metrics
- Review, create, and approve quality procedures in line with site requirements
- Drive continuous improvement initiatives across quality systems, compliance, and operational performance
Your edge (desired, not required):
- Degree or post-graduate qualification in Science, Pharmacy, or a related discipline
- Experience in a pharmaceutical, GMP, or regulated manufacturing environment
- Strong understanding of quality systems and compliance requirements
- Exposure to electronic quality systems (e.g. SAP, Trackwise or similar)
- Experience with investigations, deviations, or CAPA processes
- Familiarity with Lean or Continuous Improvement methodologies
- Exposure to high potency manufacturing or spray drying processes (advantageous)
- Strong attention to detail and confidence working with documentation and data
Why this role matters:
This is an opportunity to play a key role in ensuring that pharmaceutical products are manufactured safely, consistently, and in full compliance with global quality standards. You will be part of a team that values precision, accountability, and continuous improvement, while developing strong technical and regulatory expertise in a highly respected industry.
The next step for you:
If this opportunity is of interest, please send your CV to danielle.johnson@nextgeneration.ie or apply via our website.
All applications are treated in strict confidence.
Next Generation Recruitment specialises in Supply Chain, Procurement, Engineering, Quality, Technical, and Operations roles (permanent, contract, and temporary).
Your data will never be shared outside our organisation without your prior written consent.