Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
We are currently looking for a Qualified Person to join our team in AbbVie North Dublin. At AbbVie, our Qualified Person (QP) plays a critical role in ensuring the quality, safety, and efficacy of medicinal products. Adhering to EC Directives and Good Manufacturing Practice guidelines, the QP operates within regulatory frameworks and company policies to maintain high standards and resolve challenges impacting product performance. This role is a cornerstone in our commitment to delivering safe and compliant products.
Responsibilities
- Certify batches of medicinal products per GMP guidelines and ensure compliance with marketing authorizations.
- Ensure any changes requiring variation to the manufacturing authorisations (MIA and IMP licenses) have been notified and authorised by the relevant authority.
- Review deviation reports, Product Quality Reviews, Customer Complaints, manage CAPA and investigations, and authorise changes impacting product quality.
- Collaborate across functional teams to enhance Quality Systems; compile and communicate KPI metrics.
- Engage in Continuous Professional Development to maintain expertise in QP activities.
- Support training initiatives, safety compliance, and process improvement efforts within the team.
- Provide status updates on activities and productivity challenges; seek continuous process improvement.
- Participate in regulatory, corporate, and customer inspections.
- Conduct audits of vendors and contract facilities as appropriate.
Qualifications
Educational background satisfying Directive 2001/83/EC for Medicinal Products.
- At least 5 years of experience in drug product manufacturing, quality assurance, and regulatory interactions.
- Proficient in EU and FDA cGMPs, regulatory filings, and quality systems management.
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