Chargé(e) de Validation des Systèmes Informatisés F/H

Audensiel; France; Remote; EUR 45,000 - 65,000; Full time

Job summary

Audensiel in France is seeking a QA/Validation engineer for the pharmaceutical production site to support IS system validation strategies, archiving and data restoration.

You will write validation protocols, organize cross-functional testing and supervise execution, ensuring compliance with GAMP and 21 CFR part 11 and promoting a culture of quality and continuous improvement.

Qualifications

• Minimum 2 years of experience in similar positions at a pharmaceutical production site.
• Knowledge of GAMP and 21 CFR part 11.
• Ability to write validation protocols and organize tests with cross-functional departments (production, maintenance, QA).

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.

Skills

Teamwork

Autonomy

Interpersonal skills

Adaptability

Education

Engineering degree

Pharmacy-related degree

Job description

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:

• 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.

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

• Sense of teamwork
• Knowledge of GAMP and 21 CFR part 11
• 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.

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.