QA Compliance Specialist - 12 month contract
Core
Ensuring new products transferred to AbbVie Sligo are manufactured in accordance with regulatory requirements and company procedures.
Role type
QA Compliance Specialist (New Product Introduction)
Builds
New product transfers from development to commercialization
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance knowledge, New Product Introduction (NPI) experience, Vendor evaluation and agreement management, Analytical test method transfer and validation, Corrective and Preventive Action (CAPA) management, Material specification review, Cross-functional collaboration, Audit interface
Preferred skills
Third level qualification in science or quality
Technologies
None stated
Responsibilities
Maintain effectiveness of new product integration into quality system, Support vendor evaluation and technical agreement management, Review and approve analytical test method transfers and validation, Coordinate site review of material specifications, Manage new product exception documentation and CAPA, Generate product transfer documentation, Interface with internal auditors and regulatory agencies
Seniority
Mid-level, hands-on IC