Senior Quality Assurance Validation Specialist
When it comes to life-threatening diseases, we are one family.
We are Kiadis, a biopharmaceutical company that 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 the 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 role 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 with a competitive remuneration package, the opportunity for personal development and to contribute to making a huge difference for patients.
If you're interested in the position, please apply through the application button.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Talent Acquisition Department. We kindly request that recruiters do not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Talent Acquisition Department and the recruiting agency will not create any implied obligation.