Senior Quality Assurance Validation Specialist

When it comes to life-threatening diseases, we are one family.

We are Kiadis, a biopharmaceutical company who focusses on the treatments of blood cancers aiming to make bone marrow transplantations, safer and more efficient.

As we are a growing company, we are looking to further strengthen our Quality Assurance organization with a Senior Quality Assurance Validation Specialist based in Amsterdam, the Netherlands.

The role

As a Senior Quality Assurance Validation Specialist you will:

  • Provide quality and cGMP input and oversight for all start-up, move and/or migration project activities through commercial readiness for ATIR101 and ongoing product disposition.
  • Provide QA support for risk-based verification activities in the capacity of Quality Assurance Subject Matter Expert.
  • Review and approval of equipment/utilities validation documentation from design to post execution (Validation Lifecycle Documentation).
  • Participate in verification quality risk assessments and provide quality oversight, effective maintenance & control.
  • QA support for implementation of QC Laboratory Analytical Instruments, Manufacturing System and equipment.
  • Review and approve engineering functional area documentation (SOPs, Work Instructions, Criticality Assessments, technical reports and protocols).
  • Author, review and approve QA-related procedures.
  • Oversee the effective documentation and tracking of quality management system activities including deviations, change controls and CAPAs.
  • Review and approve Validation protocols (Computer Systems Validation, Spreadsheet Validation).  
  • Contribute to the hosting of regulatory inspections as required.
  • Represent Quality Assurance to guide various projects and technical meetings, as needed.
  • Document and report compliance issues to management.
  • Initiate continuous improvement on QA processes and updating relevant QA SOPs.
  • Support the Training Representative from a QA perspective (SME) on DI/e-Compliance/CSV/VAL
  • Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements. 
         

The ideal candidate

We are looking for someone that has the following requirements:

  • B.Sc. in Science/Pharmacy/Information Technology with a minimum of 8 years’ experience in cGMP Quality environment to include biopharmaceutical experience.
  • Minimum 5 years’ QA and Validation/CSV experience in a pharmaceutical manufacture/biopharmaceutical or biotech environment.
  • Computer systems validation knowledge with relevant experience as a validation engineer CSV.
  • Experience in a previous QA roles with Data Integrity/e-Compliance/CSV exposure.
  • Strong QC Laboratory background, familiar with analytical instruments and stand-alone equipment.
  • Strong ICH Q9 & Q10/ GAMP5 / 21CFR Part 11/ GMP & GMP Annex 11 knowledge.
  • Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Excellent communication, presentation skills and people management skills are essential.
  • Excellent time management organizational skills along with a proven ability to multi-task.
  • Capacity to set priorities as per company policies.
  • Fluency in English, other languages are a plus.

What we offer

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.

If you're interested in the position, please apply through the application button.

About Kiadis Pharma


Kiadis Pharma is a clinical stage biopharmaceutical company developing innovative products to make bone marrow transplantations safer and more effective for patients. Kiadis Pharma believes that its innovative products have the potential to address the current risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), thereby meeting a significant unmet medical need with its products.

More about Kiadis Pharma

Contact information

Kiadis Pharma
Paasheuvelweg 25A
1105 BP Amsterdam
The Netherlands

+31 (0)20 240 52 50
+31 (0)20 240 52 51
recruitment@kiadis.com