Computer Systems Validation Specialist
il y a 3 jours
Computer Systems Validation Specialist
Audensiel is seeking a skilled Computer Systems Validation Specialist to join its team. The ideal candidate will have a strong background in quality management and a deep understanding of GAMP and 21 CFR part 11.
Responsibilities:
- Implement the IS system validation strategy for archiving and restoring data
- Write validation protocols
- Organize tests with cross-functional departments (production, maintenance...) and supervise tests
- Write validation reports
Requirements:
- Sense of teamwork
- Knowledge of GAMP and 21 CFR part 11
- Editorial quality
- Autonomy, availability, good interpersonal skills
- Ability to integrate and adapt
- Graduate of an Engineering School, a bac + 5 equivalent or a Faculty of Pharmacy, oriented quality management, quality of the drug, quality control risks
- At least 2 years of experience in similar positions at a pharmaceutical production site
Audensiel is committed to combating all discrimination and promoting diversity and equal opportunities.
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