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CSV Consultant,Engineer, GAMP5, ISO 13485, ISO 62304, FDA,GMP

Eingestellt von Sentinel IT LLP

Gesuchte Skills: Support, Consultants

Projektbeschreibung

CSV consultant,engineer, GAMP5, ISO 13485, ISO 62304, FDA,GMP

My client is currently going through the largest quality remediation project globally. I have a fantastic opportunity as a CSV engineer at the companies European headquarters. I require a fluent GERMAN/ENGLISH speaker and a valid EU passport holder for this role.

Overall Responsibilities:
*Project Quality Support in the CSV Equipment Legacy Review
*Project Quality Support in CSV Equipment Remediation Projects

Tasks:
*Cover the part of the GxP-Compliance in the project.
*Creation of the Validation documentation for GxP relevant system elements.
*Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations

Extended Duties:
*Planning, coordination, execution and reporting of activities related to the project

Requirements:
*Higher education (Engineer or similar) and background in IT
*Experience in similar position or extended experience as executer required.
*Knowledge of national and international regulations and standards
*GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR, Part 820, Part 11
*CSV Experience in the area of Medical Devices Manufacturing
*Team Player
*Excellent Communication skills

Language Skills:
*English fluent, German Fluent

ABOUT SENTINEL:

In a connected world, relationships matter. For over 15 years, our recruiters have been building networks that connect the very best technologists. No one is better placed to reach the people who can help you succeed. We can name some of the global top 10 life science companies as valued clients and what we offer goes beyond the normal scope of the client-agency-candidate relationship. With our head office in the UK and our new Swiss based office, your profile will be treated with due care and attention and matched to the best possible role. We offer advice on CV structuring, interview technique and a concierge service when finalizing your contract or permanent offer with assistance in regards to booking flights/hotels, salary simulations, advice on local culture/living expenses and information on your new employer.
We have placed Quality Engineer's, CAPA consultants, Product Development Engineers, Auditors, Regulatory Affairs professionals Validation Engineers and CSV consultants across Europe and have a strong understanding of the requirements of our clients highly FDA/EUMDD/PAL regulated environments.

CSV consultant,engineer, GAMP5, ISO 13485, ISO 62304, FDA,GMP

Projektdetails

  • Einsatzort:

    Solothurn, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    4 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Sentinel IT LLP