Quality Systems Specialist (Pharmatech Industry) (mfd)

Your mission

We are searching for a Quality Systems Specialist (m / f / d) to support the establishment and management of an innovative pharmaceutical Quality Management System (QMS).

Key Responsibilities :

Reporting to the Senior Director of Quality you will :

• Coordinate and manage the daily operation of the QMS in compliance with GxP regulatory and internal standards.
• Implement and manage a system of QMS metrics and measures
• Serve as the principal point of contact for all QMS-related matters.
• Support the development implementation and continuous improvement of the QMS ensuring alignment with applicable regulations.
• Oversee and coordinate core quality processes including Document & Training Management Supplier & Audit Management Change Controls Deviations CAPAs Self-Inspections Complaints and Risk Management.
• Apply a risk-based approach and maintain the Quality Risk Register.
• Prepare review and maintain quality policies SOPs and related documentation.
• Support the rollout and training of the QMS and the implementation of an eQMS (including system administration).
• Conduct self-inspections and ensure continuous improvement initiatives are embedded.
• Support and foster a strong Quality Culture :

Provide cross-functional quality support in the design and implementation of processes as part of the QMS

Your profile

Why us

contact information

Join us in making a difference! Submit your application to be considered for this exciting opportunity.

Any questions Please contact :

Sandra Schärli

Senior Talent Acquisition Manager

mail : About us

NVision is a quantum biotech startup based in Ulm Germany with Tier 1 investors from the USA and Europe. We are just leaving stealth mode moving from local R&D to global commercialization and expansion.

We are developing a technology that will enable MRI-based imaging of real-time metabolism in the body with tremendous potential for research and applications in oncology cardiology neurology and more. Our company brings together expertise in physics chemistry engineering and medicine and we are collaborating with scientists and clinicians from top medical and research centers such as Memorial Sloan Kettering in New York MD Anderson in Texas Technical University of Munich Cambridge University in the UK and more.

NVision is developing fast robust and easy-to-use hyperpolarization technology for preclinical and clinical research in our POLARIS product line. Those devices are placed close to an MRI scanner in a research or clinical environment to produce hyperpolarized contrast agents on demand in a fast fully-automated multi-step chemical process. Key steps of the process contain fluidic transport across multiple vessels and chemical mixing and separation processes in fully-reuseable or single-use disposable fluid paths. We develop our commercial products jointly with external design and manufacturing partners and the process development as well as the design and manufacturing of prototypes is done entirely in-house.

We offer a dynamic international working environment with immense room for growth that encourages personal initiative and open communication.

Please note that for data privacy reasons well not review applications or CVs sent via email. Unsolicited applications can be submitted here .

Required Experience :

IC

Key Skills

Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP

Employment Type : Full-Time

Experience : years

Vacancy : 1