Qc Technical Specialist

2 semanas atrás


Lisboa, Portugal Hovione Tempo inteiro

.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:Define and implement quality control techniques to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements.Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.Ensure the effective and proactive flow of information and requests between the QC team and the internal and external (if applicable) stakeholders.Participate in meetings with internal and external customers as a representative of the analytical area, providing information on the status of activities.Provide collaborative and timely support in the resolution of analytical problems relating to assigned projects/initiatives.Propose and prepare changes to QC procedures or analytical methods for approval and implementation.Assure product specifications are maintained in accordance with appropriate standards and propose revisions as required.Issue and follow-up change controls.Assure good functioning equipment, planning and managing the maintenance, internal calibration plans, reference standards and internal qualifications of designated laboratory instruments.Accurately use and maintain all laboratory information systems, participating in the implementation of lab systems improvements as required.Prepare protocols, reports, QC documentation and review records to ensure compliance with cGMP and HSEE standards.Request quotations and propose the acquisition of instruments, materials and reagents to guarantee the stock control and operation of the laboratories.Manage reserve/retention samples.Initiate events and deviations in the CAPA system in accordance with the required timeframes and in partnership with appropriate colleagues.Lead and participate in root-cause investigations, guiding colleagues (as required) in the necessary investigative testing, and ensuring appropriate corrective and preventative actions are determined


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