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.
#QA Specialist (Qualified Person Required)
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 QA Specialist (Qualified Person Required) to join our site in Ballytivnan, Sligo. This person must have a minimum of 1 years acting as a Qualified Person. This role will ensure that products manufactured at AbbVie Biologics Ballytivnan Sligo meet requirements of end users, Regulatory Authorities and the company. This person will be responsible for ensuring that products manufactured at AbbVie Biologics Ballytivnan Sligo are manufactured in accordance with the relevant GMPs. The Quality Assurance Specialist (Qualified Person) is responsible for the disposition of bulk product manufactured at site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product and also to disposition bulk product as acceptable for release, or reject, to ensure patient safety based on the information available relating to the manufacture and testing of the batch.
Are you intrigued? Do you want to learn more?
A snapshot of your key responsibilities as a QA Specialist (Qualified Person required) would be:
- Ensure the batch and its manufacture comply with the provisions of the marketing authorisation.
- Ensure manufacture has been carried out in accordance with Good Manufacturing Practice.
- Ensure the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records.
- Ensure any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
- Ensure all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes.
- Ensure all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so.
- Ensure all audits have been carried out as required by the quality assurance system.
Education and Experience:
- Third level qualification in a science discipline with 5 years' experience in the pharmaceutical industry.
- MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC.
- 5 years industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
- 2 Years’ experience gained within an aseptic processing environment, ideally gained within a quality function.
- Experienced Qualified Person (minimum 1 years’ experience acting as a QP) required.
So, are you ready to join our team?
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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