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Quality Assurance Executive

Location: Galway
Experience:3-4 Years
Job Type:Permanent
Salary:Not Disclosed
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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


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