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Qualified Person - ATMP

Qualified Person - ATMP

Job Title: Qualified Person - ATMP
Contract Type: Permanent
Location: Noord-Brabant
Industry:
Salary: €TBD on application.
Start Date: 2019-07-14
Reference: J16296AB
Contact Name: Alex Butcher
Contact Email: alex.butcher@nextphaserecruitment.com
Job Published: August 15, 2019 08:39

Job Description

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, or stem cell 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.