Computer Systems Validation Officer F/M

Audensiel; Paris; Sur place; USD 46 000 - 82 000; Plein temps

Résumé du poste

Rejoignez une entreprise de transformation digitale et de conseil, où vous contribuerez à des projets innovants dans l'industrie pharmaceutique. En tant que membre d'une équipe dynamique, vous serez responsable de la mise en œuvre de stratégies de validation des systèmes d'information, en collaborant avec divers départements pour garantir la qualité et la conformité. Avec une culture d'entreprise qui valorise la diversité et l'égalité des chances, cette opportunité vous permettra de développer vos compétences tout en ayant un impact significatif sur la production pharmaceutique. Si vous êtes passionné par l'innovation et le travail d'équipe, cette position est faite pour vous.

Qualifications

• Au moins 2 ans d'expérience dans des postes similaires en production pharmaceutique.
• Orienté vers la gestion de la qualité et le contrôle des risques.

Responsabilités

• Mettre en œuvre la stratégie de validation du système d'information.
• Rédiger des protocoles de validation et organiser des tests.

Connaissances

Travail d'équipe

Connaissance de GAMP

Connaissance de la partie 11 du CFR 21

Autonomie

Compétences interpersonnelles

Capacité d'intégration et d'adaptation

Formation

Diplôme d'école d'ingénieur

Bac + 5 équivalent

Faculté de pharmacie

Description du poste

A multi-specialist player in digital transformation, business consulting, and technology consulting, Audensiel supports its clients in all sectors of activity in France and internationally in the following areas:

1. Digital: digital transformation projects, from project management using the Agile method through AMOA and application development to acceptance/testing.
2. Consulting: IT consulting within IT departments and business consulting within functional departments specifically for Banking, Insurance, and the Pharmaceutical Industry in their issues of governance, regulatory compliance, risk management, and transformation of financial departments.
3. Data/AI: Architecture and development of Big Data solutions with data engineer and data scientist consultants. Development of innovative artificial intelligence projects for our clients in the form of POC.
4. IoT: Exploitation of data from connected objects and their processing within complex interconnected systems. Design of the entire value chain to provide the best user experience for these new services and optimize productivity gains.
5. Cybersecurity: Support on the governance of our clients' cybersecurity issues. Audit and project management for data defense and security.
6. Cloud/DevOps: Support at different levels of your project, strategy and governance, architecture, development, or even DevOps.

You will work for a major player in the pharmaceutical industry in support of production to:

1. Implement the IS system validation strategy for archiving and restoring data.
2. Write validation protocols.
3. Organize tests with cross-functional departments (production, maintenance...) and supervise tests.
4. Write validation reports.

Requirements:

1. Sense of teamwork.
2. Knowledge of GAMP and 21 CFR part 11.
3. Autonomy, availability, good interpersonal skills.
4. Ability to integrate and adapt.
5. Graduate of an Engineering School, a bac + 5 equivalent, or a Faculty of Pharmacy, oriented towards quality management, quality of the drug, and quality control risks.
6. You have at least 2 years of experience in similar positions at a pharmaceutical production site.

You want to join our «Lab of excellence» which values its employees through local management and a network of experts: Come and meet us and participate in the development of our strategy!

In accordance with its ethical commitment, Audensiel is committed to combating all discrimination and promoting diversity and equal opportunities.