We have a new rolling contract opportunity working as a QA Compliance Specialist with a global biologics company in the West of Ireland. This role will report to the QA Manager and will be responsible for QA Compliance for new product introductions. The ideal candidate will have a QA Compliance background in an aseptic manufacturing environment.
Overview of your responsibilities
(full job description available on request):
Ensure new products introduced at the site meet regulatory and company requirements.
Maintain effective integration into the company’s NPI quality system.
Support product transfer from development to launch, managing quality risks.
Support vendor approval and manage technical agreements.
Review and approve method transfers and validations.
Collaborate across teams to identify and address quality issues.
Knowledge, Skills and Experience Required for the Role
Third-level qualification in science, quality, or related field.
3+ years’ experience in quality supporting new product introductions.
Strong knowledge of regulatory requirements.
Background in regulatory, quality, and new product introduction.
Desirable: 2+ years’ experience in aseptic processing (ideally in quality).
For a confidential discussion and more information on the role contact Courtney Russell.
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
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