QA Compliance & System Specialist
I am currently supporting a leading biologics manufacturer in West Dublin who is seeking a Senior QA Specialist to join their QA Compliance Materials Management team. This role suits someone who enjoys detailed quality work, material qualification and being part of a strong, collaborative QA function.
About the Role
You will oversee the qualification and quality release of materials used on site, supporting both commercial manufacturing and the clinical pipeline. This includes material qualification, QA disposition, documentation control and involvement in continuous improvement initiatives.
Key Responsibilities
* Prepare, review and approve Material Qualification documents
* Complete QA disposition for raw materials and consumables
* Author, review and approve QA procedures
* Review and assess change controls, deviations, investigations and CAPAs
* Manage assessments for supplier investigations, supplier change notifications and TSE certificates
* Support the QA Compliance Materials Management team with broader quality activities
* Contribute to Operational Excellence projects including 5S, Standard Work, LSW, Kaizen and problem solving
What You Need
* BSc in Science or related discipline
* Minimum of 3 years experience in QA or a related role within Biologics or Pharmaceuticals
* Strong understanding of cGMP requirements
* Knowledge of material qualification and SAP is a strong advantage
* Ability to work both independently and as part of a cross functional team
* Strong communication, organisation and time management skills
Why Apply
This is a great opportunity to join a high performing biologics site where continuous improvement, development and collaboration are core to the culture.
The Next Step for You
If this position is of interest to you please submit your CV to Jessica from Next Generation Recruitment using the apply button.
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