QA Compliance Specialist - Materials Management
An opportunity 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 biologics commercial portfolio and clinical pipeline.
Key Responsibilities
1. Preparation, review and approval of Material Qualification Documentation.
2. QA disposition of raw materials, level 1 & level 2 consumables.
3. Authoring, review and approval of QA-related procedures.
4. QA review, assessment and approval activities for Biologics Manufacture, as applicable, for:
* Change controls
* Deviations/Investigations
* Supplier Investigations
* CAPAs
* Other associated documentation
1. Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.
Qualifications & Experience
1. BSc in Science or related discipline with QA or related experience in a Biologics or Pharmaceutical environment.
2. A clear understanding of cGMP requirements for manufacturing and/or systems and compliance.
3. Knowledge of material qualification & SAP would be a distinct advantage.
4. 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.
5. Excellent communication and presentation skills are essential.
6. Excellent time management and organizational skills along with a proven ability to multi-task.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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