QA Manager – Qualification and Validation (QVM)

Job Description

Solvias NL, part of the international Solvias Group, is a fast-growing biotech Contract Research Organization (CRO) located at the Utrecht Science Park. We are a leading provider of high-end genetic Quality Control solutions in the fields of cell-line development, cell and gene therapy, and transgenic models, worldwide. It is our mission to improve the quality and safety of genetic research and human healthcare.

Currently, we are looking for an enthusiastic, all round QA Manager – Qualification and Validation (QVM), to support the growth and ambitions of our company, to maintain ISO/IEC17025 accreditation and obtain a GMP license.

You will be joining the QA team, currently consisting of two QA managers and one QA officer, led by the Head of QA.

Requirements

• Ensures proper qualification of equipment/instruments/computerized-systems and method
  validation/transfer/qualification/verification by guaranteeing adherence to the corresponding regulation
  requirements.
• Ensures proper re-qualification and Maintenance SOPs.
• Ensures proper Analytical Test Method descriptions are in place.
• Support in Feasibility & Robustness studies in Method Design.
• Advises on preparation of URS, DQ and IQ/OQ/PQ and Tech Transfer documents.
• Acts as first QA contact for equipment (re-)qualification.
• Ensures compliance activities including but not limited to releasing method validation, Tech Transfer,
• Qualification and Verification documents and to assigning GMP status of equipment initial (re)qualification in
  relation to supplier qualification, changes, CAPAs, audit observations and vendor change notifications.
• Ensures proper qualification of Assay & Product Development (A&PD) and Software Development &
  Bioinformatics (SD&BI) departments by supervising adherence to GMP requirements.
• Support in deviations management, CAPA and continuous process improvement in the departments of A&PD and
  SD&BI.
• Contribute to Customer and Third-Party audits as Subject Matter Expert for Qualification, Validation and Tech
  Transfer.
• Act as back up for QA managers when needed.

Benefits

Working at Solvias means working in an international and exciting environment. We are a young and dynamic team of talented people from all over the world. Our company culture is best described as informal – where hard work and team spirit are considered very important.

We offer an exciting and dynamic 0.8-1 FTE job in a vibrant, fast-growing company with an excellent remuneration and opportunities for further personal development.

Are you interested?

Please send your application letter and CV/resume to [email protected] attn. Maaike van der Weij, or contact us via the same email address for more information.

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