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Tecnico Junior Registros - Spain  

Lilly (company)


Posted on : 07 June 2017

Project Description

  • Ensure Regulatory Compliance of the products manufactured in Alcobendas.
  • Review of Specifications, Manufacturing Tickets, Stability protocols, Validation protocols, Pharmacopeias etc.
  • Quality Agreements, Site Master File.Change controls
  • Provide CMC Regulatory affairs support to manufacturing site operations for Existing/New Products.Regulatory dossiers, Variations, Renewals, Source Changes.
  • TrainingGain and maintain deep knowledge of key CMC Regulatory legislation (EU, ICH and major markets e.g., Australia, Canada, USA etc). 

Basic Requirements:  
Education and Experience
  • University Degree in Health Sciences, preferably in Pharmacy.
  • High level of English written and spoken (C1 level).
  • Master in the Pharmaceutical Industry is desirable.  

Additional Skills/Preferences 
  • Interpersonal skills: team work, customer orientation (internal/external), critical decision taking, oral and written good communication, listening attitude, leadership, problem resolution ability. Organizational skills: ability to prioritize objectives, focusing on priorities and business needs. 
  • Methodic style and Archiving is key.
  • Technical skills: knowledge on Regulatory processes and legislation. 
  • IT: user level on Microsoft tools, knowledge on IT systems that govern the Regulatory processes.