Quality Analyst

Job description

Job Title Quality Analyst Requisition: JR000015736 Quality Analyst (Open): Location: College Park, Dublin - IRL006: Additional Locations: Job Description Summary: Quality Assurance Specialist Job Description: Batch Review: Preparation of CMO documentation for batch review. Review of batch records, addressing discrepancies and escalating where required to management. Preparation of disposition and release certification for reviewed batch records. CMO Governance: Management and oversight of third party supplier activities relating to the manufacture, packaging and testing of product. Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product. Continuous monitoring of product and performance from CMOs. Quality Support and Deputation: Monitoring cold-chain transportation, for both qualification and routine CMO Maintenance: Input into Technical Quality Agreements: Post-launch support for quality activities in various countries Management of delegated projects: Audits: Drive the audit readiness programme to ensure audit compliance at all times. Quality/QMS Projects: As required. Minimum Requirements: Education / Experienc...