Beschreibung
Software Validation and Verification Support (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM+
Main tasks:
- Validation/documentation and qualification of the biochemical raw data generated in the project towards the end of the sub-processes
- Creation of test plans for testing the software and scripts that control test / test procedures in development
- Validation of test software and test scripts as well as Excel workbooks according to CSV (Computerized System Validation), which ensure test procedures / results from the development environment and link them to databases
- Qualification of test / test systems (custom built, consisting of various subsystems)
- Requirements Management (contact with stakeholders to define URS)
- Training setup Lead
- Project coordination, collaboration, planning and coordination of priorities in meetings with production and project managers
- From RMD Development in particular orders to custommade test systems
- Documentation of validation / qualification activities according to internal manufacturing process according to valid specifications and project planning
- Risk analysis for equipment / software / systems
- Support and technical advice to operators and users of equipment / systems when carrying out validation and qualification tasks
Main qualifications
- Experience in writing process documentation or qualification documentation
- Profound experience in validation, (qualification and CSV Computer System Validation) or near validation and Training programs
- At least one university degree in engineering, medicine or biophysics or completed training with proficient experience in process management and development of Project documentation in the affiliated departments of Technology, Medicine, Biology / Chemistry
- Fluency in spoken and written English (documentation in English)
- Previous experience in medical technology (ISO 13458, GMP, FDA 21 CFR 820) or GxP experience
- Introverted working technique with communicative flair within the line / stakeholder
Main advantages:
- Reputable company
About us:
With over 15 years of experience in the pharmaceutical industry, 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 professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Yves Fabien Deschamps
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