QA Validation Specialist
On-siteAthlone, Leinster, Ireland
Job Summary
Review and approve validation documents including policies, master plans, procedures, specifications, investigations, protocols, and reports for Alexion ARDU cGMP commercial and clinical requirements. Perform risk-based verification activities as a Quality Assurance Subject Matter Expert, leading non-conformance investigations and corrective/preventative actions. Conduct quality risk assessments, oversee calibration and preventative maintenance criticality assessments, and complete audits. Develop and report quality metrics while ensuring compliance with corporate policies, GMP, and regulatory requirements. Support internal manufacturing and technical groups, vendor quality management programs, and functional area documentation reviews.
Required Qualifications
- Primary Degree in Science
- Post-graduate studies as appropriate to augment primary degree
- 3-5 years' experience in Quality/validation environment
- Drug Product and Drug Substance experience
- Excellent attention to detail
- Good communication, team work and problem solving skills
- Ability to use a computer
- Ability to engage in communications via phone, video, and electronic messaging
- Ability to engage in problem solving and non-linear thought, analysis, and dialogue
- Ability to collaborate with others
- Ability to maintain general availability during standard business hours
- Ability to frequently lift/carry 15/30 pounds unassisted/assisted
- Ability to stand for prolonged periods of time
- Ability to walk and move for prolonged periods of time
- Ability to climb stairs or ladders
- Ability to gown/degown PPE and uniforms
- Ability to use a computer with a keyboard and mouse
Desired Qualifications
- Excellent interpersonal skills
- Good knowledge of relevant computer packages e.g. Trackwise, SAP and Vault
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