Manage integration of new product introductions into the AbbVie quality system, ensuring regulatory compliance. Support analytical method transfers/validations, vendor qualification, specification reviews, CAPA generation, QA metrics, audits, cross-functional coordination, and project documentation to mitigate quality risks during product transfers.
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 DescriptionPrimary duties and responsibilities of the position are as follows, other duties may be assigned:
- Responsible for implementing and maintaining the effectiveness of the integration of projects and NPI into the AbbVie quality system.
- Ensuring projects at AbbVie North Dublin meet the requirements of applicable regulatory requirements and AbbVie procedures and policies.
- Senior NPI Compliance Specialist is responsible for supporting new product transfers to the site from development through commercialization, liaising closely with local and external cross functional teams to provide direction on quality concern and ensure appropriate mitigation to address potential risk.
- Support review and approval of NPI related Analytical Test Method Transfers and/or validation.
- Support vendor evaluation and approval, management of all technical agreements from initiation review, approval and storage.
- Collaborate with local and above site functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understating 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 the management of new project related exception documentation including the generation of corrective and preventative action to prevent reoccurrence.
- Generation of quality project documentation to attest the completion of project transfer deliverables, in advance of the applicable project stage review.
- Interfaces with internal and external stakeholders as the Quality subject matter expert for new projects / NPIs.
- Responsible for the coordination of Management review and presentation to site management team as directed.
- Responsible for the coordination of site QA Metrics as required.
- QA supports Market Expansions as associated change controls regarding assessment on behalf of the site and approval as such.
- Support QA specialist team when required to meet site compliance.
- Lead and Support Site Quality projects and drive to completion and due date.
- Track and trend of quality projects on site to management .
- Support onsite internal and external audits as required.
- Third level qualification in a science discipline.
- 5 years’ experience in the healthcare / pharmaceutical industry.
- A minimum of 3 years experience in a Quality role.
- Being QP eligible is desirable.
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
AbbVie Dublin, Dublin, IRL Office
Dublin, Dublin, Ireland
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