QA Compliance Specialist - Materials Management
Headcount Solutions Limited
Full Time
Medical/Pharmaceutical/Scientific
Location
Dublin, City of Dublin, Ireland
Posted
January 29, 2025
Job Description
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...
• 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...