Senior NPI QA Specialist - Quality Transfer & Compliance

AbbVie

Dublin

On-site

EUR 70,000 - 110,000

Full time

3 days ago

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Job summary

AbbVie in Dublin is seeking a Senior NPI Compliance Specialist to drive quality processes for new product introductions and NPIs. You will collaborate with development, manufacturing and QA teams to ensure regulatory alignment and timely project delivery.

The role focuses on implementing NPI transfers, managing analytical method transfers, and coordinating audits and CAPA through the site quality system.

Qualifications

5 years’ experience in the healthcare / pharmaceutical industry.
Minimum of 3 years experience in a Quality role.
QP eligibility is desirable.

Responsibilities

Implement and maintain integration of projects and NPIs into AbbVie quality system.
Ensure projects meet regulatory requirements and AbbVie procedures.
Support transfer of NPIs from development through commercialization, liaising with cross functional teams.
Review and approve NPI Analytical Test Method Transfers/validation.
Coordinate vendor evaluation and management of technical agreements.

Skills

Quality Assurance

NPI compliance

GxP knowledge

Audit support

Education

Science degree

Job description

The role focuses on implementing NPI transfers, managing analytical method transfers, and coordinating audits and CAPA through the site quality system.

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