QA Compliance Specialist - Materials Management

Snr Specialist, QA Compliance Materials Management An opportunity for has arisen to recruit a QA Compliance Snr Specialist within the Materials Management team of a Dublin based Biotech multinational The successful candidate will support the material qualification and release activities for the new commercial drug product manufacturing facility for its biologic’s commercial portfolio and clinical pipeline. Key Responsibilities • Preparation, review and approval of Material Qualification Documentation. • QA disposition of raw materials, level 1 & level 2 consumables.

• Authoring, review and approval of QA-related procedures. • QA review, assessment and approval activities for Biologics Manufacture, as applicable, for: o Change controls o Deviations/Investigations o Supplier Investigations o CAPAs o Supplier Change Notifications (SCN) o Other associated documentation • Support establishment of Operational Excellence initiatives e.g.

, 5S / Std Work / LSW / Kaizen / P...