NPI QA Specialist - 12 month FTC
Core
Ensuring new product integration and transfers meet regulatory requirements and AbbVie quality policies from development through commercialization.
Role type
Senior NPI Compliance Specialist
Builds
New product transfers and quality system integration for AbbVie North Dublin
Domain
Pharmaceutical / Healthcare
Deliverable
client delivery
Required skills
Regulatory compliance, Quality system management, Analytical test method transfer, Vendor evaluation, Technical agreement management, Corrective and preventative action (CAPA), Quality metrics tracking, Audit support, Change control assessment
Preferred skills
QP eligibility
Technologies
None stated
Responsibilities
Implement and maintain NPI integration into the quality system, Support review and approval of analytical test method transfers, Manage technical agreements, Coordinate site reviews of material specifications, Generate quality project documentation, Lead site quality projects, Track and trend quality projects, Support internal and external audits
Seniority
Senior, hands-on IC