The Quality Assurance Manager (Bioprocessing) is responsible for managing Quality Assurance activities in the biologics facility in Dublin.
The Quality Assurance Manager (Bioprocessing) will work closely with other Quality Department personnel as part of the site Quality Department. The Quality Assurance Manager (Bioprocessing) may assume responsibilities in any of the Quality Department pillars, in accordance with business needs.
As with all site personnel, the Quality Assurance Manager (Bioprocessing) is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department and across the Dublin site.
The responsibilities of the Quality Assurance Manager (Bioprocessing) will include the following:
- Management of the Quality Assurance (Bioprocessing) team, including Qualified Persons.
- Management of batch record review, batch disposition and material status control activities associated with the biologics product.
- 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 manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
- Ensuring effective participation of the Quality Assurance (Bioprocessing) team in
- Primary Degree in Scientific discipline
- Qualified Person status is highly desirable but not essential
- More than 7 years' experience working an aseptic environment in the pharmaceutical industry, preferably in a Biologics company
- Minimum of 3 years' experience in a people management role
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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