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.
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.