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Computer System Validation (CSV) Expert

Randstad (Schweiz) AG

 
Neuchatel
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18/09/2024 100% Temporary (short-term)
Randstad (Schweiz) AG
Computer System Validation (CSV) Expert
Jobdescription

For our client, an international company based in Neuchâtel, we are looking for a Computer System Validation (CSV) Expert

General Information:

  • Start date: ASAP (flexibility until mid of October)

  • Duration: 12 months

  • Workplace: Neuchâtel

  • Workload: 100%

Your responsibilities:

The job holder is accountable for life cycle management activities of systems used in the QC Laboratories.

  • Analytical Instrument Qualification

  • Computerized System Validation

In addition, the job holder also supports the Data Integrity deployment.

  • Validation and Qualification Activities:

  • Author specification documents (URS-FS-SDCS).

  • Author plans, protocols, and reports

  • Execute and document Equipment & Software validation.

  • Oversee validation and qualification activities executed by analysts, provide training and support.

  • Assure cGMP compliant and timely implementation and maintenance of validated status of systems.

  • Conduct/participate in risk assessments, root cause analysis and investigations.

  • Identify, lead and drive improvements or change.

  • Provide technical assessments on protocols deviations and investigations.

  • Serve as SME for internal technical group discussions.

  • Quality Control Support Activities:

  • Support and interface with process owners of systems.

  • Participate to daily activities upon request (provide technical and statistical support)

Your profile:

  • Master's in engineering, Computer Science, or related technical field

  • Minimum of 5 years of relevant validation experience in the biotechnology or pharmaceutical industry

  • Fluent in French and English (C1 written and spoken)

  • Extensive experience with validation life cycle requirements for cGMPs laboratory systems

  • Experience with project management and/or leadership enabling cross functional engagement to deliver project goals and timelines.

  • A thorough knowledge of DI requirements and standard regulations for cGMPs operations

  • Provides input on project execution and acts as a consultant to management.

  • Authors and reviews protocol and reports as per established company guidelines and SOPs.

  • Identifying and communicating risks in the area of responsibility and across the site.

  • A proven ability to lead cross functional teams and deliver on tight timelines

  • Demonstrate flexible and innovative approach to work

  • Excellent collaboration skills and teamwork mindset

  • Excellent trouble shooting and problem-solving skills as well as an ability to coach and mentor self-directed teams through complex problems solving

  • Ability to challenge the status quo with a continuous improvement mindset

  • Ability to work independently in a fast-paced environment

  • Ability to manage multiple priorities and know when to escalate issues for resolution

Lucie Nasshan

About the company
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