Computer Systems Validation Specialist
il y a 2 semaines
Audensiel: A Leader in Digital Transformation
Audensiel is a multi-specialist player in digital transformation, business consulting, and technology consulting. We support our clients in all sectors of activity in France and internationally in the following areas:
Our Expertise:
- Digital: We deliver digital transformation projects, from project management using the Agile method to acceptance/testing.
- Consulting: We provide IT consulting within IT departments and business consulting within functional departments, specifically for Banking, Insurance, and the Pharmaceutical Industry, in areas such as governance, regulatory compliance, risk management, and transformation of financial departments.
- Data/AI: We design and develop Big Data solutions with data engineer and data scientist consultants, as well as innovative artificial intelligence projects for our clients in the form of POC.
- IoT: We exploit data from connected objects and process it within complex interconnected systems, designing the entire value chain to provide the best user experience for these new services and optimize productivity gains.
- Cybersecurity: We support our clients in the governance of their cybersecurity issues, conducting audits and project management for data defense and security.
- Cloud/DevOps: We provide support at different levels of your project, strategy, and governance, architecture, development, or even DevOps.
Your Mission:
You will work for a major player in the pharmaceutical industry in support of production to:
- 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.
Your Profile:
We are looking for a candidate with:
- A sense of teamwork.
- Knowledge of GAMP and 21 CFR part 11.
- Editorial quality.
- Autonomy, availability, and good interpersonal skills.
- Ability to integrate and adapt.
- A graduate degree from an Engineering School, a bac + 5 equivalent, or a Faculty of Pharmacy, oriented in quality management, quality of the drug, quality control risks.
- At least 2 years of experience in similar positions at a pharmaceutical production site.
Audensiel: A Leader in Diversity and Equal Opportunities
In accordance with its ethical commitment, Audensiel is committed to combating all discrimination and promoting diversity and equal opportunities.
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