Job Description We are now hiring a Senior NPI Quality Specialist to join our team for a fixed term contract of 12 months on our AbbVie North Dublin site .
The Senior NPI Quality Specialist is responsible for ensuring new products implementation (NPI) with a Quality interface are transferred / implemented into AbbVie North Dublin in accordance with applicable regulatory requirements and AbbVie procedures and policies.
To ensure effective and compliant transfer / local projects including NPIs to the site.
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.
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.
Support onsite internal and external audits as required.
Qualifications Third level qualification in a science discipline with 5 years' experience in the healthcare / pharmaceutical industry.
Degree or Masters level.
Being QP eligible is desirable.
A minimum of 3 years experience in a Quality role.
Excellent knowledge of regulatory requirements is essential.
Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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