Posturi disponible

R&D Analytical Manager

1.10.2018

Job description:

  • Responsible for the construction, development and validation of robust analysis methods that make analytical authorization / re-authorization applications for the company's products.
  • Use/ Troubleshoot instrumental analytical equipment with multiple software, eg. HPLC, UV-VIS, dissolution systems, potentiometry, polarimetry, or other specific analysis methods
  • Analyze and interpret the response data of analytical equipment
  • Develops and writes in English the methods of analysis to support the authorization / re-authorization documentation;
  • Validates the new analytical methods in compliance with the ICH international procedures in force;
  • Design the protocol documentation / validation report related to the developed analytical methods, or for any other documentary scientific support study generated in the development analytical department; documents are written in English;
  • Performs and interprets the analytical results of pharmaceutical formulations for the formulation samples provided by the Formulation Laboratory;
  • Develops in English the quality specifications and analysis certificates in the development stage for raw materials, intermediate products, finished products for the purpose of drafting the analytical authorization / re-authorization documentation;
  • Provides assistance in intra-inter laboratory analytical transfer, according to the company's request;

Requirements:

  • Higher education (chemistry, biochemistry, chemical engineering, pharmacy)
  • English language;
  • Pharmaceutical instrumental analysis in accordance with international monographs;
  • Specific laboratory equipment in the field;
  • Systematic and logical thinking using formatting mechanisms for purpose-result and study;
  • Responsibility, integrity and seriousness;
  • Adaptability and flexibility in conflict of ideas;
  • Ability to communicate and present in public;
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