Qualified Person
Qualified Person
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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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
