The company is one of the world's leading pharmaceutical and Biotech Company with a huge presence here in Ireland. The site is home to brand new oncology and gastrointestinal products.
The site has received huge investment over the last 2 years so the opportunity to progress is like no other.
The Quality Assurance Executive is responsible for managing the Quality Assurance team associated with production of oral solid dosage product in the production facility. In particular, the Quality Assurance Executive will assume the role of Lead Qualified Person for the release in accordance with EU Directive 2001/83/EC.
In accordance with business needs, the Quality Assurance Executive may assume responsibilities in any other work area of the Quality Department.
As with all site personnel, the Quality Assurance Executive is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department.
Day to day:
The responsibilities of the Quality Assurance Executive include the following:
- Management of the Quality Assurance team in the production facility.
- Management of batch disposition and material status control activities acting as a site Qualified Person.
- Management of review of Batch Manufacturing Records (BMRs).
- Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
- Management of the Change Control process, ensuring controlled implementation of all GMP related changes.
- Management of QA oversight of routine manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
- Ensuring effective participation of the Quality Assurance team in production and other site meetings.
- Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
- Participation in the site Internal Audit programme.
- Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
- Minimum of 5 years' experience in the pharmaceutical industry in a Quality role.
- Experience of oral solid dosage manufacture.
- Primary Degree in a scientific discipline
- Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC.Not sure yet? No CV ready? Please give me a call for more information.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales