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;