AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Want to make a global impact? We offer that.
Want to be part of a Great Place to Work in Ireland? We offer that too.
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.
We are recruiting a Quality Specialist (12 months FTC ) to join our diverse team in Clonshaugh, Dublin. Quality Assurance team based in Clonshaugh. Their primary focus will be to enhance and maintain the quality oversight and compliance systems of validation activities on the Clonshaugh site. This position will primarily be involved in supporting and coordinating day to day activities in the areas of cleaning, facilities and equipment validation and will participates in knowledge transfer activities to become a QA Subject Matter Expert on new and developing processes. The position will also support the maintenance of the site equipment calibration programme and ensure that equipment performance is continually demonstrated
Are you intrigued? Do you want to learn more?
- Represent the site Quality Assurance Department as SME in compliance
- Manage/input into SAP/POMs refinement initiatives.
- Liaise with Site Operations and BTS functions as necessary to support compliance initiatives
- Co-ordinate compliance activities for all systems for Manufacturing, Laboratory, and IT areas.
- Track and provide relevant quality metrics to Quality Management as required
- Perform quality risk assessment of all GMP documentation systems and support stakeholders in the mitigation of compliance risks.
- Prioritize risks and work with all site departments to ensure documentation and system compliance
- Be current with regulatory requirements
- Ensure alignment between the local and global compliance and QRM initiatives
- Ensure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines and fulfill AbbVie’s requirements
- Write or review and approve protocols, reports and SOP’s to effect compliance gap remediation as appropriate
- Initiate action reports or deviation reports for any applicable nonconformance
- Seek process innovation and continuous process improvements
- Recognize and report to immediate supervisor any issues or deviations from accepted standards
- Provide status updates on own activities and productivity challenges according to defined procedures
- Complete and conform to all training requirements for job role, including company-required and job role-specific training
- Carry out and assist in the ongoing training of new and existing personnel, as appropriate
- Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses
So, what do you need to do this role?
- Relevant industry experience (5+ years preferred) including strong knowledge in GMP regulations working in a pharmaceutical, biotechnology or medical device industry
- 3+ years of experience in a quality assurance role
- Experience in compliance requirements including Eudralex, 21 CFR Parts 210, 211, ICH Q9, Q10 and other applicable regulatory requirements
- SAP or ERP system experience
- Excellent communication and interpersonal skills, including technical writing
- Strong analytical and problem-solving skills
- Maintain credibility and integrity.
- Goal focused
- Demonstrate passion and energy
It’s important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
Job Type: Experienced
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