.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. Assure cGMP compliance before, during and after validation/qualification activities of systems/equipment and manufacturing processes by assuring that all necessary procedures are implemented and are being followed. Promote the Qualification and Validation vision and energize less experienced team members to provide an outstanding service. Promote the importance of high-quality levels and the importance of a continuous improvement culture in core company activities. Contribute for the alignment of Qualification and Validation methodologies among Digital (Automation/IT), Engineering, Maintenance, Production Areas and Quality Control, when applicable, to benefit systems compliance. Provide input to Plan and/or establish Qualification and Validation requirements for each project within the Team. Establishes the required qualification activities of new or changed systems and/or facilities within the change control process. Manage Qualification and Validation (Q&V) procedures to ensure that are updated as per the latest regulatory guidance and industry best practices. Develop and coach the Qualification & Validation Team. Propose qualification/validation related procedures and documents to be followed. Participates or support internal or external/customer audits and health authority inspections. Control/close/approve deviations, CAPA, improvement plans, and change control related to Qualification and Validation of Systems under her/his responsibility
