Quality Engineer
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Job Location:
Monthly Salary:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
- Coordinating the quality system ensuring full compliance by all personnel with its requirements.
- 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
- 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
- Supporting all aspects of inspection readiness including preparation activities logistic activities and generation of follow up responses and management of CAPA responses.
- 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.
- Third level Science qualification desirable.
- Clear understanding of working within a regulated environment.
- Establishing excellent working relationships through hands on approach.
- Ability to use sound judgment to make effective decisions within appropriate timeframes.
- Proven to be self-directed self-motivated and ability to prioritize competing priorities.
- Excellent communication and presentations skills both written and oral.
- 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.
- 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
