QA Operations Specialist – Biotech Manufacturing
Company: RECRUITERS Agency
- Location: County Meath, Ireland
- Seniority: Mid level
- Employment type: Contract
- Posted: Yesterday
- Offer language: English
Job description
An exciting opportunity has arisen for an experienced QA Operations Specialist to join a state-of-the-art, single-use, multi-product biopharmaceutical manufacturing facility in Dunboyne, Co. Meath.This is an excellent opportunity to join a growing biotech manufacturing operation, providing quality oversight across manufacturing activities, commercial operations, technical transfers and validation programmes. You will work closely with Manufacturing, Engineering and Technical Services teams, playing an important role in maintaining GMP compliance and supporting operational excellence.
The Offer
- Salary: €55,000–€90,000 DOE
- Shift Premium: Additional 23%
- Contract: 11-month contract
- Location: Dunboyne, Co. Meath
- Working Pattern: 24/7 shift rotation
Key Responsibilities
- Provide QA oversight across manufacturing operations, ensuring compliance with cGMP and internal quality standards.
- Review and approve batch records, deviations, investigations, discrepancies and CAPAs.
- Manage and support quality systems, including change controls and batch documentation review.
- Provide quality oversight for qualification, validation activities, technical transfers and commercial manufacturing.
- Review and approve validation protocols, reports and documentation associated with new products and materials.
- Partner with Manufacturing, Engineering and Technical Services to resolve quality issues and support daily operations.
- Support regulatory submissions, inspection readiness and health authority inspections.
- Drive continuous improvement initiatives, quality metrics and effective root-cause investigations.
What We're Looking For
- Degree or postgraduate qualification in Science, Pharmacy or a related discipline.
- Minimum 4 years' experience in Quality Assurance within a GMP-regulated environment.
- Strong experience supporting manufacturing operations within pharmaceutical or biotech manufacturing.
- Experience with deviations, CAPAs, change controls and batch record review.
- Knowledge of validation, qualification and technical transfer activities.
- Experience participating in internal and external audits.
- Strong understanding of GMP regulations, quality systems and continuous improvement methodologies such as Lean, Six Sigma or DMAIC.
- Excellent communication, problem-solving and stakeholder management skills.
- Flexibility to work a 24/7 shift pattern.
Apply today!
For a confidential discussion, contact Emma O’Connell on +353 1 632 5032 or email your CV to emma.oconnell@recruiters.ie.
By applying, you agree to RECRUITERS storing your CV securely within its applicant tracking system (ATS), Bullhorn. Your details will never be shared with any third party without your consent.
