Qualified Person
Qualified Person
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Job Description
The Qualified Person (QP) at AbbVie Biologics Ballytivnan Sligo is responsible for ensuring the compliance and quality of our pharmaceutical products. This role requires expertise in quality assurance practices within an FDA and EMEA approved environment to maintain product safety and integrity. As a QP for the site you will work closely with our products throughout their manufacturing lifecycle up until release from the site.
Responsibilities
- Ensure compliance with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice and Annex 16 requirements.
- Certify that each batch is manufactured and checked according to relevant laws GMPs and product specifications at AbbVie Biologics Ballytivnan Sligo.
- Oversee the disposition of bulk products determining release or rejection based on manufacturing and testing data.
- Assess and resolve day-to-day quality issues ensuring products meet quality and safety standards.
- Support cross-functional teams in process improvement and cost efficiency initiatives.
- Provide technical leadership and collaborate with stakeholders to enhance product quality and process optimization.
- Make informed decisions within quality systems adhering to regulatory standards and handle quality queries from the operations team.
- Promote a culture of excellence in quality and compliance throughout the organization.
- Participate in internal and external audits ensuring readiness and compliance with quality standards.
Qualifications :
- Essential: Bachelors degree in a science discipline and a minimum of 5 years of experience in the pharmaceutical industry.
- MSc in Industrial Pharmaceutical Science or equivalent recognized for QP status under Directive 2001/83/EC Article 49.
- Experience as a QP on a license preferrable
- Experience in aseptic processing and quality functions.
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
