Qualified Person (Senior)
This company is one of the world’s leading biopharmaceutical companies. Through acquisitions and mergers, they have expanded rapidly in their short history and now boast more than 10,000 employees, and offices in more than 40 countries. This organisations growth strategy is to focus on developing and marketing innovative speciality medicines for symptomatic conditions to serve significant unmet patient needs. Their strategic priorities are to drive optimum performance of their existing products, enabling access to these medicines for patients today, and building their pipeline through research and development and business development to deliver future treatment access for patients. Due to continued expansion, an exciting new position has arisen for a Qualified Person (QP) to be based at this organisations Corporate HQ here in Dublin.
- The Qualified Person will work in the Disposition Team of the External Biologics Quality Organisation at the organisation’s Corporate HQ in Dublin – this team is responsible for material disposition, including QP certification, of material manufactured at contract manufacturing operations on behalf of the company.
- This individual will have primary responsibility for batch disposition activities.
- The QP is the person responsible for all batch certification and associated responsibilities as detailed in 2001/83/EC as amended.
- This individual will be responsible for the successful, timely completion of goals and objectives for the Dublin-based disposition team. This position will have direct reports (Qualified Person(s) and Quality Assurance (QA) Specialists).
- Additionally, the QP will participate in the qualification of CMO’s/contract laboratories and participate in the oversight of CMO’s and contract laboratories.
- Eligible to work as a Qualified Person meeting the requirements of Article 49 of Directive 2001/83/EC of the European Parliament, as amended.
- Bachelor’s degree in chemistry, biology or a related discipline.
- Very strong experience working in Quality Assurance including strong experience working as a Qualified Person performing disposition of sterile medicinal products and biological medicinal products.
- Thorough understanding of quality systems, EU GMP and GDP and US Code of Federal Regulations Title 21, Part 210 and 211.
To learn more apply on line or call Shane Browne on +353 1 6321865
Salary: On Application
Location: Dublin West