QA Compliance Specialist - 12 month contract

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

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The NPI Compliance Specialist is responsible for ensuring new products transferred to AbbVie Sligo are manufactured in accordance with applicable regulatory requirements and AbbVie procedures and policies. To ensure effective and compliant transfer of New Products to the site.

Responsibilities

• Responsible for maintaining the effectiveness of the integration of new products into the AbbVie NPI quality system.
• Ensuring that new products manufactured at AbbVie Ireland NL B.V. meet requirements of applicable regulatory requirements and AbbVie procedures and policies.
• NPI Compliance Specialist is responsible for supporting new product transfers to the site from development through to commercialization, liaising closely with local and external cross functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk.
• Support vendor evaluation and approval, management of all technical agreements from initiation, review, approval, and storage.
• Support review and approval of NPI related Analytical Test Method Transfers and / or validation.
• Collaborate with CMC QA, R&D, S&T, and other functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understanding of the quality compliance and provide input on quality concerns.
• Coordination of site review of new product related material specification documents including but not limited to, intermediate specifications, API specifications, Drug Product specifications, raw material specifications, and excipient specifications.
• Support review and approval of new product related analytical Test Method Transfers and/or validation.
• Support the management of new product related exception documentation including the generation of corrective and preventative action to prevent reoccurrence.
• Generation of product transfer documentation to attest the completion of product transfer deliverables, in advance of the applicable product transfer stage gate review.
• Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matter expert for new products and technology transfers.
• Adheres to and supports all EHS & E standards, procedures and policies

Qualifications

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

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html