Validation-Qualification Officer in the pharmaceutical industry (M/F)

As part of the development of our activities in the pharmaceutical industry, EKIUM is looking for a Project Quality Assurance Engineer - Utilities Qualification (M/F) to work at our client's site in Toulouse. Within the Quality Assurance Qualification, Validation & Projects department, you will contribute to the implementation of investment projects dedicated to the modernization of the site's equipment and installations. You will work on various projects, particularly in the fields of utilities, HVAC, compressed air, purified water, and centralized technical management systems. Your main responsibilities will be as follows:

• Guarantee the application of qualification policies to modified equipment and installations.
• Prepare project documentation: URS, tender specifications, and associated documents.
• Write validation master plans (VMP), criticality analyses, and risk analyses.
• Ensure quality management of projects: Change Control, CAPA, and monitoring of non-conformities.
• Write qualification protocols and reports: FAT, SAT, IQ, OQ, PQ, and QP as applicable.
• Participate in the execution of qualifications in collaboration with user teams and engineering.
• Review and contribute to the drafting of quality documentation: procedures, operating modes, etc.
• Ensure schedule monitoring, traceability of quality decisions, and knowledge transfer.
• Work in parallel on several AIP projects and different qualification phases.

Profile With an Engineering degree or equivalent, you have proven experience in Quality Assurance, qualification, and validation within the pharmaceutical industry. You specifically possess skills in the following areas:

• Utilities qualification: HVAC, AHU, cleanrooms, compressed air, and purified water.
• Writing risk analyses, managing Change Control and deviations.
• Knowledge of European and American GMP standards, Annex 15, 21 CFR Part 11, GAMP5, and ICH Q9.
• Mastery of ALCOA+ principles and computerized system validation (CSV).
• Writing skills, ability to synthesize information, rigor, and autonomy.
• Ability to work in a team and communicate with various stakeholders.
• Professional English (B2 level), particularly for writing GMP documentation and communicating with international suppliers or teams.
• Experience in BMS (Building Management System) and GTC (Gestion Technique Centralisée) qualification is an asset.