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QA Manager / QP

QA Manager / QP

Job Title: QA Manager / QP
Contract Type: Permanent
Location: Noord-Brabant
Industry:
Salary: €To be discussed on application
Start Date: ASAP
Reference: J16249
Contact Name: Alex Butcher
Contact Email: alex.butcher@nextphaserecruitment.com
Job Published: May 30, 2019 11:35

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 newly qualified QP 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
• Cell 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 newly qualified QP or be studying to become a QP.