Validation Engineer and Computer Systems Specialist
il y a 4 semaines
Validation Engineer and Computer Systems Specialist
Audensiel is seeking a skilled Validation Engineer and Computer Systems Specialist to join its team. As a key member of our digital transformation team, you will be responsible for ensuring the validation of computerized systems in the pharmaceutical industry.
Key Responsibilities:
- Develop and implement validation master plans (POS or VMP)
- Participate in risk analyses and establish and monitor validation schedules
- Identify and monitor key users and write URS, test sheets, and define user needs
- Write qualification protocols, run IQ/OQ/QP tests, and write qualification reports
- Be comfortable with the validation of one/more of the following tools: Excel files, software (SAP, Trackwise, etc.), CRM, laboratory equipment, or production with human-machine interface (HMI) type automata
- Draft and monitor documents related to validation processes (protocols, procedures, reports, etc.)
Requirements:
- Master's degree in a relevant field
- Knowledge of pharmaceutical industry processes in the field of validation of computerized systems
- Rigor and sense of relationship are essential assets for this position
Audensiel is committed to fighting discrimination and promoting diversity and equal opportunities.
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