Computer Systems Validation Officer F/M

il y a 1 mois

Paris, Île-de-France Audensiel Temps plein

Job Summary

Audensiel, a leading player in digital transformation, business consulting, and technology consulting, is seeking a skilled Computer Systems Validation Officer F/M to support a major player in the pharmaceutical industry. The successful candidate will be responsible for implementing the IS system validation strategy for archiving and restoring data, writing validation protocols, organizing tests with cross-functional departments, and supervising tests.

Key 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

  • Expected Competencies:
  • Sense of teamwork
  • Knowledge of GAMP and 21 CFR part 11
  • Editorial quality
  • Autonomy, availability, good interpersonal skills
  • Ability to integrate and adapt
  • Graduate (e) 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

About Audensiel

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:

  • Digital: digital transformation projects, from project management using the Agile method through AMOA and application development to acceptance/testing.
  • 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.
  • 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.
  • 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.
  • Cybersecurity: Support on the governance of our clients' cybersecurity issues. Audit and project management for data defense and security.
  • Cloud/DevOps: Support at different levels of your project, strategy, and governance, architecture, development, or even DevOps.

Why Join Audensiel

Audensiel values its employees through local management and a network of experts. We offer a dynamic and challenging work environment that allows our employees to grow and develop their skills. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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