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.Join a Market Leader: Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market. Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites. Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life. You will be responsible to: Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices. Apply and develop knowledge of Quality's Computerized Systems and participate in area processes, procedures and projects of computerized system developed in-house or off-the-shelf, with the guidance of more senior colleagues. Support the evaluation of design documents against regulatory and Hovione compliance requirements as well as throughout its life cycle. Apply a risk-based approach throughout the life cycle of the Computerized Systems taking into account patient safety, data integrity and product quality. Understand and apply policies for Computerized Systems life cycle management. Perform validation activities of the Computerized System projects and support teams to ensure compliance with Regulatory and Industry Standards throughout systems' life cycle. Participate as part of multi disciplinary work groups with Quality Assurance, Information Systems, User Areas and other Departments/Sites and contribute to the adequate and timely completion of all validation activities. Collaborate in the definition of the required Qualification and Validation strategies for different Computerized Systems: Analytical equipment, Manufacturing equipment, DCS, PLC and other stand-alone software. Issue/prepare/review protocols and reports (i.E., DQ, IQ, OQ and PQ), relating to the Qualification of Computerized Systems and other validation/qualification documents. Support in reviewing Computerized System change controls, deviations, incidents submitted by any Department/Site
