QA Manager – Computer System Validation (CSV)

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 – Computer System Validation (CSV), to support the growth and ambitions of our company, to maintain ISO/IEC17025 accreditation and contributing to successful tech transfer initiatives. You will be joining the QA team, currently consisting of two QA managers, led by the Head of QA.

• Ensures proper qualification of computerized-systems and transfer/qualification/verification by guaranteeing adherence to the corresponding regulation requirements.
• Provides QA oversight and guidance for all activities related to the validation and lifecycle management of computerized systems, ensuring compliance with relevant regulations (e.g., GxP, 21 CFR Part 11, EU Annex 11, ISO/IEC 17025).
• Ensures the validation, re-validation, and periodic review of computerized systems in alignment with applicable regulatory requirements and internal procedures.
• Ensure proper re-qualification and Maintenance SOPs.
• Advises on preparation of URS, DQ and IQ/OQ/PQ and Tech Transfer documents (software/System).
• Acts as first QA contact for (re-)qualification.
• Ensures compliance activities including but not limited to releasing method validation, Tech Transfer, Qualification and Verification documents, changes, CAPAs, audit observations and vendor change notifications.
• Ensures proper qualification of Software Development & Bioinformatics (SD&BI) departments by supervising adherence to relevant regulations.
• Support in deviations management, CAPA and continuous process improvement in the departments 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.

Requirements

• >4 years working experience in pharmaceutical industries and ISO17025 controlled environment preferable in CSV across the system lifecycle.
• Very good working knowledge in EU and US GMP regulations relevant for CSV, validation/transfer and corresponding compliance systems.
• Solid know-how in EU and US GMP regulations relevant for computerized systems validation à
• 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.

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