Computer System Validation (CSV) Expert
Veröffentlicht:
19 September 2024Pensum:
100%- Arbeitsort:Neuchatel
For our client, an international company based in Neuchâtel, we are looking for a Computer System Validation (CSV) Expert
General Information:
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Start date: ASAP (flexibility until mid of October)
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Duration: 12 months
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Workplace: Neuchâtel
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Workload: 100%
Your responsibilities:
The job holder is accountable for life cycle management activities of systems used in the QC Laboratories.
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Analytical Instrument Qualification
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Computerized System Validation
In addition, the job holder also supports the Data Integrity deployment.
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Validation and Qualification Activities:
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Author specification documents (URS-FS-SDCS).
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Author plans, protocols, and reports
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Execute and document Equipment & Software validation.
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Oversee validation and qualification activities executed by analysts, provide training and support.
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Assure cGMP compliant and timely implementation and maintenance of validated status of systems.
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Conduct/participate in risk assessments, root cause analysis and investigations.
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Identify, lead and drive improvements or change.
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Provide technical assessments on protocols deviations and investigations.
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Serve as SME for internal technical group discussions.
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Quality Control Support Activities:
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Support and interface with process owners of systems.
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Participate to daily activities upon request (provide technical and statistical support)
Your profile:
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Master’s in engineering, Computer Science, or related technical field
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Minimum of 5 years of relevant validation experience in the biotechnology or pharmaceutical industry
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Fluent in French and English (C1 written and spoken)
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Extensive experience with validation life cycle requirements for cGMPs laboratory systems
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Experience with project management and/or leadership enabling cross functional engagement to deliver project goals and timelines.
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A thorough knowledge of DI requirements and standard regulations for cGMPs operations
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Provides input on project execution and acts as a consultant to management.
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Authors and reviews protocol and reports as per established company guidelines and SOPs.
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Identifying and communicating risks in the area of responsibility and across the site.
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A proven ability to lead cross functional teams and deliver on tight timelines
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Demonstrate flexible and innovative approach to work
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Excellent collaboration skills and teamwork mindset
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Excellent trouble shooting and problem-solving skills as well as an ability to coach and mentor self-directed teams through complex problems solving
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Ability to challenge the status quo with a continuous improvement mindset
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Ability to work independently in a fast-paced environment
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Ability to manage multiple priorities and know when to escalate issues for resolution
Lucie Nasshan
- +41 58 201 55 50
- Basel Professionals IT & Life Sciences