Qualification & Validation Manager - Quality Assurance

1 semana atrás

Lisboa, Portugal Hovione Tempo inteiro

Qualification & Validation Manager - Quality Assurance Lisboa Qualification & Validation Manager - Quality AssuranceLouresLoures, Lisboa, Portugal Join a Market LeaderHovione 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- 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- 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 projectwithin 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.- Propose improvements to the area as appropriate and solve problems.- Make quality, safely and timely decisions within the Qualification and Validation tasks under her / his responsibility.- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).- Promote the importance of management through the applicability of LEAN tools and others considered relevant for the area objectives- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.We are looking to recruit a Candidate:- Masters' degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field- Previous GMP experience required- Technical background preferred- Typically requires 5 years of relevant experience in Quality and Qualification and Validation, preferably in an industry environment (mandatory).- Preferably with previous experience (minimum 2 years) in operational areas preferentially in installation, qualification or maintenance of Facilities and Equipment- Experience in leading others in project context- Effective time management skills and the ability to multitask.- Track record of overachieving targets- Strong understanding and knowledge of Quality, Engineering (applied to Processes and HVAC systems), cGMP, ICH and ISO guidelines, Risk Assessment applied to Qualification and Validation- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.- Fluency in English and Portuguese is a requirement.- Computer literate with good working knowledge of the MS Office package.#J-18808-Ljbffr

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    1 semana atrás

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