QA Compliance & Systems Specialist
Morgan McKinley Dublin
Reporting to the Senior Manager, QA Compliance Materials Management, the Specialist will support the material qualification and release activities 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 TSE (Transmissible Spongiform Encephalopathy) Certificates
o Other associated documentation- Be a core team member of the QA Compliance Materials Management team engaging in other support activities as required.
- Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.
Qualifications & Experience
The successful candidate must possess:
- BSc in Science or related discipline with QA or related experience in a Biologics or Pharmaceutical environment
- A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
- Knowledge of material qualification & SAP would be a distinct advantage.
- Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix to meet accelerated timelines.
- Excellent communication and presentation skills are essential.
- Excellent time management and organizational skills along with a proven ability to multi-task.
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