Quality Assurance Associate
CK Group are recruiting for a Quality Assurance Associate to join a biopharmaceutical company at their site based in Dun Laoghaire on a contract basis for 12 months.
This is a shift based position covering 24/7 operations
Salary: From €37.70 per hour depending upon experience
Quality Assurance Associate Role:
- Provide real-time Quality oversight and support for Inspection Operations
- Perform Visual AQL audits as part of the inspection process
- Perform QA Reserve Sample Inspections as part of the Annual Reserve Inspection program and in support of Customer Complaint investigations
- Review and approval of Deviations and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
- Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities
- Hold a third level qualification(Degree) in Biology, Biotechnology or related discipline or have equivalent working experience
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
- Knowledge of applicable Regulatoryrequirements, and ability to evaluate compliance issues
- Operational Excellence experience
- A background working in pharmaceuticals, biotech, medical devices or similar industry
Company: Our client is one of the worlds leading manufacturersof biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis.
Location: This Quality Assurance Associate role will be based at our clients site in Dun Laoghaire, County Dublin
Apply: Entitlement to work in Ireland is essential. For more information, please contact Natasha on 44 1246 457739 or email firstname.lastname@example.org. Please quote reference 50007 in all correspondence.