Descripción de la oferta
We are a partnered with a Global Pharmaceutical company who work with APIs, finished dosage forms, and branded pharmaceuticals, for both human and animal health. The company manufacture products for 100 countries, and their mission is to provide greater access to high need medicines across the globe. They have 18 state of the art facilities, located in more than 50 countries. This is for one of their mainstay sites, based in the heart of Madrid, they seek an experienced Quality manager with an IT background/skill set to help develop and implement their new QMS.Role Overview: This role sits in the Global Quality Systems team, and will play a major role in one of the companies most important projects. The role intends to develop, then roll out and implement their new Quality Management System. You have the opportunity to lead an experienced team, then grow and develop this in the long-run!Responsibilities: Support of new Trackwise implementations.Support Trackwise and other enterprise systems (e.G., ERP, ELN, CDS, QMS)Participation in validation of the workflowsParticipation in the training and support of junior staffParticipation in the training and technical support activities of key users at the sites.Leadership of a global team that cover CSV and Quality digital systems.Define and drive digital strategy for Quality systems.Full oversight of computerized system validation activities.Maintaining compliance with relevant regulatory standards, inc, FDA.Collaborate with IT, Quality Operations, and Regulatory Affairs to ensure system alignmentProactively identify risks and drive corrective and preventive actions (CAPAs)Qualifications: Advanced degree in Chemistry, Pharmacy, Chemical Engineering, or related field.Excellent English communication skills, and Spanish proficiency is a plus.Experience working with Quality Management Systems.Minimum of 3 years' experience in pharmaceutical or biotechnology industry.#J-18808-Ljbffr
