Description

Reporting to the Metrology Manager, you ensure the qualification and metrology of equipment, processes, and systems. You intervene throughout the entire lifecycle of validation activities within a regulatory framework.SpecialistOur client is a company in the pharmaceutical sector. It distinguishes itself by its expertise in the development and production of innovative solutions.Missions- Define validation strategies based on a risk-based approach- Write, coordinate, and execute qualification protocols to ensure the qualified maintenance of systems and equipment- Manage documentation (procedures, protocols, reports)- Manage external service providers (monitoring, document review)- Participate in deviations and CAPA as an expert- Contribute to new equipment acquisition projects- Evaluate the impacts of changes on validated systems- Collaborate closely with engineering, production, quality, and maintenance teams- Participate in audits and regulatory inspectionsProfile- Higher education (engineer or university)- Experience in validation in the pharmaceutical or medical device industry- Mastery of validation processes and the V-model lifecycle- Good knowledge of GMP standards- Knowledge of GAMP5, ICH, ISO standards is a plus- Excellent writing skills and documentary rigor- Analytical mind and ability to propose solutions- Proficiency with computer tools and team spiritConditions and Benefits- A dynamic and quality-oriented environment within the framework of a temporary assignment- Varied technical projects with high added value- Competitive conditions with prospects for development jid71523d6aen jit0626aen jpiy26aen