CSV Specialist (m/f/d)
Responsibilities
- Support and interface with process owners of systems and take part in daily activities upon request (provide technical and statistical support)
- Execute and documents Equipment & Software validation
- Oversee validation and qualification activities executed by analysts, provide training and support
- Ensure 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
Profile
- Master’s in engineering, Computer Science, or related technical field
- Solid validation experience in the pharmaceutical industry
- 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
- Ability to identify and communicate risks in area of responsibility and across the site
- Fuency in English (C1) and French (C1)
Benefits
- Long-term planned project
- Dynamic environment
- Continuous support during the assignment
- Individual all-round care: Support throughout the entire application phase
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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