Loading...
Entry LevelFull-timeAPI
Salary Range
$18,360 - $24,840 /year
This salary is estimated based on similar roles. The actual salary may vary.
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 compliance inputs.
• Coordinate review of product-related material specifications, including API, drug product, raw material, excipient, and intermediate specifications.
• Support exception documentation and CAPA actions to prevent recurrence.
• Prepare product transfer documentation for stage gate reviews.
• Act as a subject matter expert during internal audits and external regulatory inspections.
Free to sign up. Takes 30 seconds.
About Abbvie
Abbvie is a global biopharmaceutical company specializing in the research, development, and commercialization of innovative therapies. Headquartered in North Chicago, Illinois, the company was founded in 2013 following the spin-off of Abbott Laboratories' pharmaceutical division. Abbvie operates at the forefront of the biotechnology and pharmaceutical industries, focusing on addressing complex diseases and improving patient outcomes through scientific advancement. The company's primary products include treatments for immunology, oncology, and neurology, with its flagship drug, Humira, being one of the best-selling medications globally. Abbvie is known for its robust pipeline of investigational therapies, leveraging cutting-edge research and clinical trials to bring novel treatments to market. Its target audience includes patients, healthcare providers, and payers, with a particular emphasis on those suffering from chronic and life-threatening conditions. Key features of Abbvie's offerings include targeted therapies, personalized medicine approaches, and a commitment to regulatory compliance and safety. Abbvie has achieved significant milestones, including maintaining a leading position in the global pharmaceutical market and generating substantial revenue through its innovative portfolio. The company's unique value proposition lies in its dedication to scientific excellence and patient-centric care, supported by a strong pipeline and strategic investments in research and development. Abbvie's market position is further strengthened by its global reach, collaborative partnerships, and a reputation for delivering transformative therapies.
