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. [email protected] on Twitter, Facebook, Instagram, YouTube and LinkedIn. QA Compliance Specialist Primary Cork, Ireland Req ID 2302841 Category Quality Assurance Division AbbVie Want to make a global impact? We offer that. 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 ae looking for a QA Compliance Specialist to join our team in AbbVie Cork. This is a 12 month FTC role whichcontributes to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations with primary responsibility for the quality assurance compliance activities in the Cork Site. A snapshot of your key responsibilities as QA Compliance Specialist would be: Implementation, maintenance and development of QA systems. Reviewing the GMP documentation e.g, SOPs, reports, methods, specifications, validation protocols, quality contracts etc., and Exceptional Documents e.g. NCRs/PNCRs, Planned Deviations etc. Writing and reviewing QA department procedures and reports e.g. protocols, SOPs, environmental reports etc. Reviewing and Approving other departmental procedures and reports. Internal Auditing (when required) of FLI Departments and external auditing (when required) of Material and Service Suppliers (including Supplier Management). Alerting the QA Compliance Manager in case of detection of a discrepancy / non-compliance. Assisting in the preparation and reviewing of QA department reports and metrics e.g. monthly quality report, discrepancy reports, exceptions reports, KPI reports. Reporting and communication to QA Compliance Manager on key events and issues etc. via normal in house reporting structure e.g. meetings, formal reports etc. Participate in initiatives and action plans for the development of QA and improvement of GMP compliance. Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients Address regulatory requests from both internal and external customers. Are you intrigued ? Do you want to learn more ? For this role, you will have: Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 3 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries a significant advantage. Ideally, you would have a technical background and understanding of the audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance. Proficient in Microsoft Word & Microsoft Excel Excellent written and oral English communication skills. So, are you ready to join our team? Apply to AbbVie today ! 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. Join our talent network and receive AbbVie news and job alerts to your inbox. First name Last name Email address Phone number Interested In Please select a category or location option. Click “Add” to create your job alert. Category Location Quality Assurance, Cork, Munster, Ireland Remove Confirm Email Phishing scam alert As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages. Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.