QP - Cell Therapy
A Global Leader within the Biopharmaceutical industry currently based in Co. Dublin are looking for a Qualified Person for Cell Therapy to join their team as part of an exciting green fields project for their new start of the art facility.
Your New Role
As the you will be responsible for the release of drug product in accordance with EU Directive 2001/83/EC.
You will work closely with other Quality department personnel as part of the site Quality department.
In your role as QP you will be responsible also for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality department and across the company's site.
Your New Company
The Company is highly driven in the research and development of life-changing medicines to bring better health and a brighter future for patients.
Through this they strive to be the leader in innovate products especially in the areas of oncology and gastroenterology.
You will be working in a highly collaborative work environment, where integrity is a core value and diversity is seen as a key player in the creation of an outstanding company culture.
Your Duties and Responsibilities as QP
- Management of batch disposition and material status control activities associated with Cell Therapy Products acting as QP.
- Management of review of 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 associated with Cell Therapy manufacture and testing, ensuring controlled implementation of all GMP changes.
- QA oversight of routine manufacturing, testing and relating activities to ensure on-going cGMP compliance.
- 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 documentation for regulatory submission and participation in regulatory affairs discussions.
Your Education & Experience
- Primary Degree in a scientific discipline
- Must requirements of a Qualified Person as per EU Directive 2001/83/EC.
- Minimum of 5 year's experience in the pharmaceutical industry in a Quality role.
- Experience of sterile manufacture is essential.
- Biologics manufacture experience is desirable.
Your Skills & Competencies
- Excellent knowledge of GMP for ATPM.
- High level of initiative.
- Excellent verbal and written communication skills.
- Strong project management and organisational skills.
- Ability to adapt to changing priorities.
What's in it for you?
As part of this opportunity you will be joining a well-established Global Biopharmaceutical Company as part a of a growing dynamic team.
Alongside, working with a Company that has a great culture reputation in the market, you will receive a competitive salary and benefits package.
Your Next Step
If this sounds like the right role for you, please reply with an updated CV for immediate consideration.
Or if you would like to hear more please feel free to contact Ciara McGrath on 01 8883477 or by email.
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