NPI Quality Compliance Specialist

AbbVie; Sligo; On-site; EUR 55,000 - 75,000; Full time

Job summary

AbbVie in Sligo is seeking an NPI Compliance Specialist to ensure new products transferred to the site are manufactured in compliance with regulatory requirements and AbbVie procedures. You will support the transfer of new products from development through commercialization, coordinating with cross-functional teams to address quality concerns.

The role requires a third-level science/quality qualification and at least three years' quality experience, with strong regulatory knowledge and

Qualifications

• Third level qualification in a science, quality or relevant discipline.
• Minimum of three years’ experience in a quality role supporting new product introductions.
• Strong knowledge of regulatory requirements is required.

Responsibilities

• Maintain effectiveness of the integration of new products into the AbbVie NPI quality system.
• Ensure new products meet regulatory requirements and AbbVie procedures and policies.
• Support transfers of new products from development to commercialization with cross-functional teams.
• Support vendor evaluation and management of technical agreements from initiation to storage.
• Assist review and approval of NPI related analytical Test Method Transfers and validation.
• Collaborate with CMC QA, R&D, S&T and other groups to identify quality concerns and mitigations.
• Coordinate site reviews of product-related specifications (API, Drug Product, excipients).
• Support management of exception documentation and corrective/preventive actions.
• Generate product transfer documentation ahead of stage gate reviews.
• Interface with internal auditors and external regulators as SME for new products and technology transfers.
• Adhere to EHS standards and AbbVie policies.

Skills

Quality systems

Regulatory knowledge

Cross-functional collaboration

Education

Third level qualification in science/quality

Job description

AbbVie in Sligo is seeking an NPI Compliance Specialist to ensure new products transferred to the site are manufactured in compliance with regulatory requirements and AbbVie procedures. You will support the transfer of new products from development through commercialization, coordinating with cross-functional teams to address quality concerns.

The role requires a third-level science/quality qualification and at least three years' quality experience, with strong regulatory knowledge and