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.
Senior Compliance Specialist
Welcome to AbbVie!
At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives worldwide. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact felt within healthcare and beyond.
We are now recruiting a Senior Compliance Specialist at our Manorhamilton Road Site in Sligo on a 1-year fixed-term contract basis.
In your new role you will coordinate the development and maintenance of company’s quality system in compliance with all applicable regulatory requirements and to ensure that products manufactured at AbbVie meet requirements of end users, of regulatory authorities and of the company.
You will be responsible for documenting and establishing a quality system which ensures full compliance with all regulatory and AbbVie requirements
So, if you are ready to make a significant impact with your next role and want to be part of an exciting project, read on to find out more and get your application started today!
Key activities include but are not limited to:
- Coach and mentor your team ensuring successful career development, a culture of continuous learning and encouraging an atmosphere of involvement, open communication and effective teamwork
- Supports coordinating the quality system, ensuring full compliance by all personnel with its requirements.
- Supports a Quality Risk Management approach for all site activities and participates during the coordination Risk Control Strategies (RCS) and FMEA activities as required.
- Auditing the quality system with other management personnel.
- Initiation and Completion of Quality related ERs as required.
- Providing quality guidance, support, and approval on all site/system validation activities.
- Ensuring that products manufactured at AbbVie Ireland Pharmaceutical Operations meet requirements of end users, of regulatory authorities and of the company.
- Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings e.g., SPM.
- Monitoring quality performance and advising management personnel on major quality issues.
- Ensuring all plant personnel are fully aware of quality and cGMP requirements
- Implementation review for Policy documents
- Supporting all aspects inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books.
- This position is crucial in identifying any causes of non-compliance of the quality system while maintaining effective communication with all employees.
- Adheres to and supports all EHS & E standards, procedures, and policies
For this role you will need;
Education and Technical Skills -
- Third level qualification in a science, quality, or relevant discipline.
- Minimum of two years’ experience in a quality role
- Strong knowledge of regulatory requirements is required.
- High level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times
- Proven problem-solving skills and the ability to adapt to new regulatory requirements
- Results driven and accountable striving to meet all targets and metric standards as set by site/department and division leaders
- Strong communication skills both verbal and written are required for the execution of this role
So, if all this sound like the right role for you, then apply today!
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: Temporary Work
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