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.
AbbVie employees work every single day to discover and address many of the world's most pressing health challenges. Our work helps people live better lives. When you have patients depending on your solutions, you look for the best people and, when we find them, we make it our business to treat them well.
We are currently sourcing a hardworking QA/QP Specialist to join our new created biologics team in AbbVie, Ballytivnan, Co. Sligo. Reporting to the Quality Operations Lead, you will ensure that products manufactured meet requirements of end users, Regulatory Authorities, relevant GMPs and the company. You are 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.
Does this sound like the right next career move for you? then read on....
Here is a snapshot of your responsibilities:
• You will ensure the batch and its manufacture comply with the provisions of the marketing authorisation and that manufacture has been carried out in accordance with Good Manufacturing Practice.
• You will ensure the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records and 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.
• As QA/QP Specialist, you will 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.
• Support all audits and their completion as required by the quality assurance system.
• A 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
• 2 Years’ experience gained within an aseptic processing environment, ideally gained within a quality function is preferred