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**QA Manager - Qualification and Validation (QVM)**
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 2 QA managers and 1 QA officer, led by the Head of QA.
**Tasks and Responsibilities of the QVM**
- 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.
**We are looking for a QVM who...**
- >4 years working experience in pharmaceutical industries and GMP controlled environment preferable in Quality Control, Production or Quality Assurance.
- Very good working knowledge in EU and US GMP regulations relevant for equipment qualification, maintenance, method validation/transfer and corresponding compliance systems.
- Solid know-how in EU and US GMP regulations relevant for computerized systems validation à GAMP5.
- Excellent communication and decision-making skills.
- Ability to provide solutions for complex challenges and work independently in a team environment.
- Solution oriented, precise, organized.
- Good inter-personal skills.
- Energized and open-minded.
- Willingness to learn and carry out new and complex tasks.
- Proactive attitude.
- Excellent knowledge of written and spoken English.
**What we offer**
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?**
Soort dienstverband: Fulltime, Parttime
Verwacht aantal uur: 32 - 40 per week
Aanvullende vergoedingen:
- Vakantiegeld
Arbeidsvoorwaarden:
- Pensioen
- Reiskostenvergoeding
Werkschema:
- ma-vr
Werklocatie: Hybride werken in 3584 CM Utrecht
Deadline sollicitaties: 30-10-2024
Verwachte startdatum: 01-11-2024
