IS Validation & QA Manager (M/F)

Driven by deeply humanist values, INNOTHERA, a family-owned and independent laboratory, has relied on innovation and technology for over 100 years for the continuous improvement of the treatment of daily pathologies worldwide.

As part of its development, the INNOTHERA group is looking for an IS VALIDATION & QA MANAGER (M/F). Job Description

• Ensure that the computerized systems used in a pharmaceutical environment are:

Compliant with regulatory requirements Validated based on risk (GAMP5 approach) Secure in terms of data integrity Compliant in terms of traceability and drug serialization As part of IT projects, he/she leads or coordinates qualification and validation activities, in compliance with user needs, regulatory requirements, and the objectives of digital transformation projects.

• Ensure the management of the Quality Management System

Profile sought:

Master's degree/Engineer in Life Sciences (IT, automation, industrial systems) or Pharmacist. 5 to 10 years of experience in Computerized System Validation and Quality Assurance in the pharmaceutical industry or in a regulated environment.

Good knowledge of GAMP 5, Annex 11, 21 CFR Part 11 frameworks and Data Integrity requirements.

Good knowledge of GMP/GDP frameworks.

Mastery of quality processes (CAPA, Deviations, Change Control, Audits).

Knowledge of ERP and GxP systems. Understanding of IT/OT environments and industrial automated systems Documentary rigor, analytical mindset, autonomy, and good interpersonal skills.

Professional English.