QP / Qualified Person
|Job Title:||QP / Qualified Person|
|Salary:||€To be discussed on application|
|Contact Name:||Alex Butcher|
|Job Published:||June 12, 2019 11:30|
An exciting opportunity has arisen with a Netherlands based Stem Cell company. Their patented protected technology is based on the expansion and differentiation of stem cells derived from umbilical cord blood. They have several assets in oncology, one due to move into phase II stages.
Due to growth within the company they are seeking a Qualified Person or a QA Manager who is studying to be a QP to join the team.
The successful candidate will ensure that their cell and gene therapy products are manufactured and released according to quality guidelines, regulatory requirements and trial needs. You will also be involved in the set-up and validation of the manufacturing processes. As QP you provide guidance and direction to Development, Production and Quality staff regarding compliance with quality standards and procedures.
Suitable candidates will need to possess skills/experience in the following areas: -
• M.Sc. or PhD degree in biotechnology, biology or equivalent
• Advanced therapy, ATMP experience is essential
• Experience working in a GMP regulated environment
• Strong QA experience – Document control, Deviation & CAPA management, Change control
• You will either be a Qualified Person or be studying to become a QP.
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