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QUALITY REGULATORY API TECHNICIAN

Descripción de la oferta de empleo

Who we are?Today, we are a pharmaceutical group with a track record spanning over 45 years and a footprint in more than 50 countries, led by Leandro and Lucas Sigman. Our overarching goal is to improve people's health all over the world, providing accessible, effective, safe, quality medicines through our various business units, underpinned by continuous investment in R&D and cutting-edge technology at all our centres.Global ResponsibilitySupport the Global API Quality and Regulatory Director in evaluating the current requirements of the Regulatory Agencies, for what refers API Chemo sites', CMOs, JVs sites, specifically from chemistry and solid-state perspective.The candidate will collect the necessary information and documents from the manufacturers, review them from chemistry and solid-state perspective, and will interact, with the support of the Global API Quality and Regulatory Director with the manufacturing sites, or as support in case of interactions with the Authorities with the aim to prepare and maintain active the regulatory affairs dossiers, necessary for registering APIs where/when required.The candidate will contribute to respond to the queries received from the Regulatory Agencies and Customers from chemistry and technical perspective.The candidate will support the Global API Quality and Regulatory Director in defining the strategies for replying to Deficiency Letters of Customer technical requests.Specific ResponsibilitiesCollect the information about manufacture and controls of the APIs to the manufacturers and verify the adequacy for the initial filings, as well for answering the deficiency letters, specifically from chemistry and solid-state perspective, with the aim to prepare and maintain active the regulatory affairs dossiers, necessary for registering APIs where/when required.As process leader keep monitored the process lifecycle from chemistry perspective in all the changes proposed and implemented.Support the head of the function in implement and report as head of projects that the priorities established are afforded and without unknown concern, specifically from chemistry and solid-state perspective.Support the head of the function in complaints and customer technical requests.Follow up of the milestones of the projects, by periodical meetings and reporting.Support the organization with interdepartmental teams meeting for implementing the strategies defined along with the Global API Quality and Regulatory Director.Requirements and personal skillsEducation: University Level in Pharmacy, Chemistry, or other relevant Science discipline.Languages: Fluent English and Spanish.Experience (years/area): 2 years experience with technical quality documentation elaboration in a regulated environment (GxP). Preferable in the Chemistry and Solid-State areas
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Detalles de la oferta

Empresa
  • Insud Pharma
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 06/10/2024
Fecha de expiración
  • 04/01/2025
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