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Job ID :
72094BR
Location :
Italy - Ferentino
:
Job Description
The resource will support the Regulatory Affairs Department in ensuring regulatory compliance of the production site through:
  • Verification of conformity to the finished product registration dossier, both for the production and quality control aspects;
  • Transposition of the registration dossier contents and the customer's needs in the specification documents, transmitted to the company departments through the application of the Change Control procedure;
  • Transposition of external inputs in terms of regulations (directives, regulations, ICH, EMA, FDA Guidelines, GMP Standards) and corporate policies into internal documentation;
  • Provision of the necessary documentation for ministerial inspections
  • Write/Review of the Module 3 CTD sections ensuring consistency with internal documentation and preparation of GAP Analysis;
  • Support clinical or commercial registration in EU/US/ROW countries;
  • Check regulatory compliance on raw materials, finished product and components used during the manufacturing process or its simulations;
  • Check internal documentation compliance with the main Pharmacopoeias in force (USP-NF/EP/JP);
  • Revise the Quality Master documents (material specifications/finished product, MBR) vs CTD dossier and standards;
  • Verify documentation of API/BDS manufacturers from EU and extra EU countries in accordance with European Directive 2011/62/EC;
  • Prepare documentation to submit essential/non-essential changes to AIFA;
  • Prepare import permits for human blood derivatives and revise the documents related to the quality of plasma before submission to AIFA;
  • Evaluate the changes to the system, from regulatory point of view;
  • Write national SMF and PIC/S;
  • Support the site registration in Japan.
REQUIREMENTS:
  • Degree in CTF, Pharmacy, Chemistry, Pharmaceutical Biotechnology
  • Experience at least 2-3 years in RA/Quality Control/Quality Assurance/TT
  • Good level of English



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