COMPUTER SYSTEM VALIDATION SENIOR

Are you passionate about learning? Do you want to make a difference by managing Multi-Projects Consulting?Are you ready to work in Global multisite company?We are looking for a Computer System Validation Senior Consultant to join our Barcelona team.Your Challenge (Describe the missions): Our team of highly experienced, top-level consultants carry out key projects for companies around the world in the areas of: * GxP readiness. Assessing and targeting improvements while ensuring there are no gaps in quality or compliance across all phases of the product development and manufacturing lifecycle.* Design Review of new facilities, commissioning and qualification of equipment and utilities are also key aspects of this service.* Digital transformation. Assisting on how to redesign and optimize manufacturing quality processes to take advantage of the latest technology (cloud-based solutions, IoT or AI/machine learning), validate those systems and ensure data integrity.* Medical Devices. Latest regulatory framework and manufacturing requirements specific to smart/digital devices as well as health tracking apps.* Quality management System (QMS). Advisory service helping our customers to achieve a systematic approach to Quality design and maintenance, and optimized business processes. We also deploy the TrackWise Digital Quality Management Software. Your main responsibilities: * Reporting directly to CSV Area Manager:* Collaboration on GxP compliance projects, especially in Computerized Systems Validation projects * Active role in the delivery of Validation of Computerized Systems related projects including customer service, defining project approach and guiding the execution of the different validation activities, leading follow-up meetings, writing and reviewing of validation deliverables , supporting test execution and reporting. This Job is for you IF:* Bachelor's degree in chemistry or engineering.* Experience working in pharmaceutical environment and knowledge of the pharmaceutical and chemical business, manufacturing, and quality processes (GxP compliance, validation, and quality systems management, GMP Annex 11, 21CFR part 11, Data Integrity Principles, GAMP 5, ...). * Experience in computerized systems validation (ERP, eDMS, eQMS, LIMS, Laboratory systems, EBRMES, SCADAs, …) * Experience in data integrity assessment/remediation projects.* Experience in change or incident management regarding computerized systems* Experience in IT infrastructure projects and Agile methodologies is a plus.We offer:* Benefits: Competitive salary according to experience, additional extra-legal vacation days, and other competitive benefits.* Teamwork: highly qualified staff with numerous years of experience, always available to help. * Flexibility: Hybrid mode, autonomy, reduced workday each Friday, flexible hours.* Global Company: Growing global company and multicultural team. * Learning program: Training and development program* Continuous training and English and Chinese lessons* Occasionally teambuilding, social events * Excellent culture and work environment.Young and enthusiastic team of consultants. Montreal Associates is acting as an Employment Agency in relation to this vacancy.