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Want to lead a high performing team? We offer that too
Welcome to AbbVie!
Our employees work every day to discover and address many of the world's most pressing health challenges. When you have patients depending on your solutions, you look for the best people to join the team. At AbbVie Manorhamilton Road in Sligo, we are recruiting an experienced Quality Operations Manager. So, if you are driven to make a real impact on a global scale, read on to find out more and apply….
Reporting to the Quality Director, in this role. you are responsible for ensuring that all commercial products produced are manufactured in compliance with the applicable GMPs and the site Quality System.
Here is a snap shot of your day to day:
- Coaching, leading and developing your Quality Operations team, ensuring all product unexpected events are fully investigated, root cause determined and appropriate CAPA implemented, including provision of manufacturing quality support
- Partnering with all departments to ensure compliance with the requirements of the manufacturing process:
- US Food and Drugs Administration, 21 Code of Federal regulations Parts 210 and 211 and Q7A.
- European Commission, Good Manufacturing Practices for Active Pharmaceutical Ingredients, ICH Q7A.
- European Commission, Good Manufacturing Practices, Volume 4, Medicinal Products for Human and Veterinary use.
- AbbVie International Quality Assurance Policies. Ensuring that products manufactured meet requirements of end users, Regulatory Authorities and of the company.
- Liaising with AbbVie International Quality Assurance. Ensuring QA Director is kept informed of operational failures to ensure corrective/preventive action is undertaken where required.
- Working with QA Director and Quality Management Team to ensure site meets its customer, quality, service, regulatory and financial goals.
- Ensuring all plant personnel are fully aware of operational quality requirements.
- Ensuring compliance review on change requests are performed on operational /manufacturing related changes.
- Management and monitoring performance of ER and CAPA process.
- Verification of effectiveness of corrective/preventive actions arising out of product, and process exceptions.
- Providing quality guidance, support, and approval on all site/system validation activities
So what Education & Experience do you need?
- You will have a 3rd level degree in a relevant technical (science/engineering) discipline with 5 -7 years’ experience in the healthcare/pharmaceutical industry.
- 5 -7 years industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
- QP Qualification desirable, not essential.
So, if you are ready for the next step in your career and lead an award-winning team? Then join AbbVie!
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.
Job Type: Experienced