Quality Assurance Specialist - Pharmaceutical Industry
Drive quality excellence at a premier biotech facility.
Join a dynamic team at our state-of-the-art site in Carlow, Ireland - a key manufacturing center producing critical pharmaceutical products during an exciting expansion phase. As a Quality Assurance Specialist, you'll safeguard compliance and operational excellence across drug manufacturing operations. Reporting to the QA Manager, leverage your expertise for batch release, audits, and continuous improvement in a high-impact role.
Key Benefits of the Role
- Collaborative culture: Work with high-performing teams prioritizing safety, cGMP compliance, and innovation.
- Strategic impact: Support global supply of essential medicines from cutting-edge facilities.
Core Responsibilities
- Ensure cGMP compliance in manufacturing, testing, and documentation processes.
- Review batch records, deviations, and change controls for data integrity and Right First Time KPIs.
- Lead/support internal/external audits and inspections as subject matter expert or auditee.
- Join daily QA Tier meetings to monitor progress, resolve issues, and ensure site readiness.
- Develop, revise, and train on SOPs, quality procedures, and risk assessments (e.g., FMEA, root cause analysis).
- Handle OOS/CAPA investigations and continuous improvement using tools like 5 Whys and Fishbone diagrams.
- Build a proactive, compliant quality culture through cross-functional collaboration.
Qualifications We Value
- Bachelor's degree or higher (ideally in Life Sciences, Pharmacy, or related field).
- 2-3 years in pharmaceutical QA, with cGMP experience in manufacturing environments.
- Strong knowledge of Quality Management Systems, LIMS, and regulatory standards (FDA, EMA).
- Desired: Batch review/release, audit experience, deviation management, and validation support.
The Next Step for you:
Should this position be of interest to you please forward your CV from Next Generation Recruitment or apply on our website.
Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.
Applications are in strict confidence.
Next Generation will never share your data outside of our organisation without your prior written consent.
