Analytical Expert Service within Medical Device activities for NV R&D / no-094

SimplyVision GmbH; Basel; Presencial; CHF 166.000 - 240.000; Jornada completa

Descripción de la vacante

SimplyVision GmbH in Basel, Switzerland, is seeking an Analytical Expert Service within Medical Device activities for NV R&D (m/f/d) on a freelance basis.

You will act as the single point of contact for analytical activities, create project-specific analytical methods, select labs, and lead outsourced projects. Strong knowledge of ISO norms, Ph. Eur., USP, statistics (Minitab) and English fluency are required. Swiss payroll option exists for local residents.

Formación

• Expert on ISO norms and pharmacopeias (Ph. Eur./USP).
• Advanced analytical mechanical methods and their applications.
• Excellent coordination and communication across device project teams.
• Strong knowledge of statistical data analysis using Minitab.
• English-speaking with excellent verbal and written skills; NRV/GLIMS/1-QEM preferred.

Responsabilidades

• Act as single point of contact for analytical activities within the project.
• Create project-specific analytical methods and transfer to labs.
• Select testing laboratories based on resources and strategy.
• Lead outsourced analytical project activities and manage external partnerships.
• Contribute to regulatory documents and support project registrations including inspections.
• Oversee all analytical activities and meet client needs.

Conocimientos

Analytical expertise

Statistical data analysis

Cross-functional coordination

Communication skills

English language fluency

Herramientas

Minitab

NRV system

GLIMS

1-QEM

Descripción del empleo

For our customer located in Basel, Switzerland we are currently looking for a: Analytical Expert Service within Medical Device activities for NV R&D (m/f/d)

• Duration: 04.01.27 – 31.12.27
• Contract: Freelance. If you’re located in Switzerland it’s also possible to get employed by us (swiss payroll)

Tasks & Responsibilities

• Act as Single point of contact for analytical activities within the project for device related testing activities.
• Creation of project specific analytical methods including transfer to internal and external laboratories.
• Selection testing laboratory in-line with resource availability, capability and in/outsource strategy for both projects.
• Leading outsourced analytical project activities at external laboratory and contribution of management external partnership for both independent projects.
• Contribution and review regulatory documents and support project registration activities including presentation at inspections for both independent
• In-depth knowledge of statistical data analysis, strong practical skills in statistical software (e.g. Minitab)
• Oversee and lead all analytical activities of assigned projects; meet customer needs

Must Haves

• Expert on ISO norms, European Pharmacopeia (Ph. Eur.) and United States Pharmacopeia (USP), their interpretation and application.
• Expert on analytical mechanical methods and their application
• Excellent coordination and communication skills with cross functional device project-team members as well as on drug product level
• In-depth knowledge of statistical data analysis, strong practical skills in statistical software (e.g. Minitab)
• Highly motivated and able to handle high workload consistently delivering very high quality.
• Specific requirements: English-speaking (excellent verbal and written), access to NRV, GLIMS, 1-QEM (Novartis internal systems) preferable, European working hour preferred (for alignment on working packages and status)