AbbVie
Senior NPI Compliance Specialist
Job Description
Job Description
AbbVie is seeking a Senior NPI Compliance Specialist to support the compliant transfer of new products to AbbVie Sligo for a fixed-term contract of 12 months. The role ensures products are manufactured in line with regulatory requirements, AbbVie procedures, and quality standards, working closely with cross-functional teams from development through commercialisation.
Responsibilities
- Maintain the effectiveness of the new product integration within the NPI quality system.
- Ensure new products meet applicable regulatory requirements and AbbVie policies.
- Support product transfers from development through commercialisation, including quality risk assessment and mitigation.
- Manage vendor evaluation and approval, including technical agreements.
- Review and approve NPI-related analytical test method transfers and/or validation.
- Collaborate with CMC QA, R&D, S&T, and other functions on quality issues and...