Kiadis Pharma is a biopharmaceutical company based in Amsterdam, The Netherlands. We focus on the treatment of blood cancers and inherited blood disorders aiming to make bone marrow transplantations, a risky procedure that is often the last hope for patients, safer and more efficient. This means we have a passionate team that is dedicated to make a huge difference for patients.
If you are up to the challenge and would like to be part of our team, we are currently looking for a
QUALIFIED PERSON (QP)
within the Quality Assurance team
The QP is responsible for the final release of the batch of our pharmaceutical product. In this role you review all the batch files, which encompass information from every involved department. In this role you will be trained to the specific characteristics of our product and the manufacturing steps.
Your responsibilities include but are not limited to:
- Certification of each batch of the finished product
- Following the principles and guidelines of GMP. Ensure all requirements under references have been met prior to release of a batch
- Validation of the principal manufacturing and testing processes
- Checking all necessary tests have been performed
- Ensure that the legal requirements regarding imported products have been fully met
- Provide QP GMP declarations in support of importation activities and will be expected to maintain an up to date awareness of regulatory issues
- Carry out auditing of third party GMP facilities involved in the manufacturing of medicinal products used in clinical studies
- Acting as the main liaison with the Inspectie Gezondheidszorg en Jeugd (IGJ).
The ideal candidate
- Has a M.Sc. degree in Pharmacy, Biotechnology, Biology or equivalent
- Is licensed as QP as defined in the DIRECTIVE 2001/83/EC
- Has at least five years of experience working in a GMP regulated environment
- Is experienced with Advanced Therapy Medicinal Products (ATMP)
- Has experience in performing audits of third party providers and support of the internal audit program to enable permanent inspection readiness
A challenging position in an innovative, fast growing, biotechnology company. Working in a fast-paced dynamic environment brings the opportunity to make your own mark within the organization.
You will be rewarded a competitive remuneration package, the opportunity for personal development and to contribute to make a huge difference for patients.
For further information
Please contact Caroline Vermeulen (Sr Specialist Talent Acquisition) or e-mail your motivation letter and resume at firstname.lastname@example.org
If you’re interested in the position
Please apply through the application button via this link.
Acquisition will not be appreciated. Any unsolicited CV’s received by agencies will be treated as direct Kiadis applicants – without any fee obligations.
Keywords: Vacancy, Research, WO, Master, Pharmacy, Biotechnology, Biology, Amsterdam, Noord-Holland.