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Quality Assurance Executive

Reference:ALGT-533310 Location: Galway
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Quality Assurance Executive
Our client a global biopharmaceutical manufacturer are currently recruiting for a Quality Assurance Executive for a permanent opportunity based in Galway. The ideal candidate will have experience of quality system aspects including: Investigations, Deviation management, CAPAs, Complaint handling, change management and batch release.

• Investigation of product complaints of affiliate sites & associated vendors and of third parties
• Support the affiliate sites in investigations related to escalations
• Review of Product Quality Review (PQR) Reports for affiliate injectable sites
• Preparation and review of SOPs
• Preparation of monthly, quarterly, annual KPI and Management review data as required
• Provide training to QA Regional staff & QA Affiliate staff at the relevant manufacturing & packaging site in GMP practices and procedures
• Liaise with Clinical, Manufacturing and Packaging sites as required
• Support other activities of the Regional Quality team such as but not limited to:
o Batch records review
o Deviations review
o Product technical files
o Continuous improvement tasks / projects
o Preparation and control of Technical Agreements and Confidentiality Agreements
o Support Annual Reports submission, Product Development and Product Launch’s
o Support sites inspections
o Provide technical transfer and process validation support. Review equipment, process, method validation protocols and reports
o Review of stability data, stability protocols, stability reports for affiliate Injectable sites

• Degree in a life science or pharmacy and 3-5 years of experience in quality control or quality assurance within a pharmaceutical or medical device company
• Experience of sterile injectable manufacturing and third party and affiliate site quality management desirable but not essential
• Knowledge of Quality Control testing, Knowledge of chemistry and troubleshooting within a QC laboratory background desirable but not essential
• Knowledge of Quality Risk Management Systems
• Knowledge and experience in the use of Trackwise Software is an advantage

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252

QA Specialist Planner Facilities Engineer Supply Chain Research and Development Chemist Biotechnology Process Engineer Formulation Chemist Hospital Sales Rep Biopharmaceutical Quality Assurance Dublin Medical Affairs Research and Development Engineer Dublin South Supply Chain Administrator Pharmaceutical Cork Research and Development Scientist Formulation Scientist Medical Device Dublin City Centre Engineering Supply Chain Senior Lecturer Connected Health QA Executive Nurse Associate Regulatory Affairs Director EHS Specialist Product Specialist Sales Executive Manufacturing Coordinator Kildare Quality Manager Microbiologist Manufacturing Executive Business Development Supply Chain Coordinator Food Scientist Healthcare Clinical Research Regulatory Affairs Specialist Regulatory Affairs EHS Engineer Regulatory Affairs Executive Dublin West Business Development Executive Chemistry Supply Chain Specialist Principal Scientist Contract Senior Research and Development Engineer Production Supervisor Scientific Limerick Quality Control Manager PhD Project Lead Quality Assurance Officer QA Manager Qualified Person Regulatory Affairs Manager Sales Development Executive QA Analyst Regulatory Affairs Officer Microbiology BD Manager Dublin North QA Supervisor Automation Engineer QA Director Contract Microbiology Analyst Technical Project Manager Life Science Galway Project Engineer Regulatory Affairs Republic of Ireland Life Science Sales Manager Engineering Sligo Business Development Manager Process Development Engineer R and D Manager Equipment Engineer Microbiology Lab Supervisor