CSV Specialist in QC Lab (m/w/d)
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Neuenburg, Schweiz |
Temporary Employment
Job title: CSV Specialist in QC Lab
Industry: BiotechSkills: Computerized System Validation
Start of project: 14.10.2024
The job holder is accountable for life cycle management activities of systems used in the QC Laboratories of Neuchâtel – Switzerland with a focus on:
Validation and Qualification Activities:
Quality Control Support Activities:
Experience:
Language & IT Skills:
Key Skills, Abilities, and Competencies:
Duration of the project : 12 months
Location: Neuenburg, Schweiz
Duties:
The job holder is accountable for life cycle management activities of systems used in the QC Laboratories of Neuchâtel – Switzerland with a focus on:
- Analytical Instrument Qualification
- Computerized System Validation
- In addition, the job holder also supports the Data Integrity deployment in the department following cGMP, Takeda policies and EHS requirements.
Validation and Qualification Activities:
- Author specification documents (URS-FS-SDCS).
- Author plans, protocols, and reports
- Execute and documents 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)
Experience:
- Master’s in engineering, Computer Science, or related technical field
- Minimum of 5 years of relevant validation experience in the biotechnology or pharmaceutical industry
- 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 area of responsibility and across the site.
Language & IT Skills:
- Fluent in French and English (C1 written and spoken)
- Proficiency in all aspects of standard IT tools
Key Skills, Abilities, and Competencies:
- Strong project management skills to support project delivery and operational readiness
- 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
- Effective communicator and strong decision maker
- Demonstrated ability to synthesize information and defend conclusions publicly
- Demonstrated ability to give and receive feedback
Referenznummer: 15150
Branche: Biotech
Beginn des Projekts: 14.10.2024
Dauer: 12 months
Anstellungsart: Temporary Employment
Kontakt
Luca Furler