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
What you do, is what we need. Making a difference begins here. And takes all of us.
Welcome to AbbVie!
We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.
The role of the Quality Engineer at AbbVie Ballytivnan will hold responsibility for documenting and establishing a quality system which ensures full compliance with all regulatory and AbbVie requirements.
The Quality Engineer will have responsibility to assess and report on the effectiveness of the quality system to senior management. The position holder will work closely with the Quality Management teams, Business Units, OPEX Professionals and other Quality Systems personnel.
The Quality Engineer must show competence to drive the site forward in terms of quality, compliance and efficiency. This will require technical, organizational and people management skills and a passion for quality. The Quality Engineer will work to meet company goals and objectives, customer requirements and the regulatory obligations laid down by the FDA, EU and regional Ministries of Health.
What you will do:
- Maintain a strong relationship with Quality systems Manager, quality personnel within the Business Units, the quality function and customers.
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Coordinating the quality system, ensuring full compliance by all personnel with its requirements.
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Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings by supporting metrics generation, as required
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Be the Quality point of contact for various Quality System and Compliance Activities including: Training & Documentation, Quality Metrics Generation/ Reports, Quality Training Deliverance including GDP/Data Integrity, Nonconformance Quality Support, Internal Audit Programme Maintenance and Support, Inspection Readiness & Inspection Support, Quality Systems and Compliance Approvals, as required
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Supporting all aspects of inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of CAPA responses.
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Adheres to and supports all EHS standards, procedures and policies.
Qualifications
What you will need:
- 5+ years’ experience of working within quality role within Pharmaceutical/Medical Device industry.
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Third level Science qualification, desirable.
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Clear understanding of working within a regulated environment.
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Establishing excellent working relationships through hands on approach.
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Ability to use sound judgment to make effective decisions within appropriate timeframes.
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Proven to be self-directed, self-motivated and ability to prioritize competing priorities.
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Excellent communication and presentations skills, both written and oral.
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The ability to present in a clear and concise manner to team members, managers and SLT. 8. Be able to work in a fast-paced environment whilst being able to adjust readily to meet priorities and deliver results.
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Ability to lead if required.
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
