Eurofarma

Senior Technical Documentation Analyst – R&D, DMF

Eurofarma

full-time

Posted on:

Location Type: Hybrid

Location: Itapevi • Brazil

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Job Level

Senior

About the role

  • Responsible for the technical and regulatory assessment of documentation (DMF – Drug Master File) and for prospecting/sourcing manufacturers of active pharmaceutical ingredients (APIs);
  • Responsible for Nitrosamine risk assessment for APIs and finished products;
  • Responsible for evaluation of API impurity profiles;
  • Contact and negotiation with national and international API manufacturers and suppliers;
  • Responsible for monitoring and meeting project targets for projects under development, as well as providing support to the team and interfacing departments;
  • Initiating purchase requests, tracking and approving sample shipments;
  • Preparation/review of SOPs (Standard Operating Procedures);
  • Responding to ANVISA requirements and audits.

Requirements

  • Education: Bachelor's degree in Chemistry, Pharmacy and/or Chemical Engineering;
  • Postgraduate degree, Master’s and/or PhD in Organic Chemistry preferred;
  • Advanced/Fluent English;
  • Required knowledge of ANVISA regulations (including the Regulatory Framework for APIs: DIFA / CADIFA), as well as international guidance (ICH, AOAC, WHO, EMA, FDA, Health Canada, among others) related to active pharmaceutical ingredients and drug registration/post-registration;
  • Required experience in development, forced degradation, stability studies and analytical validation of APIs;
  • Required knowledge of API synthesis and evaluation of impurity profiles (elemental, inorganic, organic, genotoxic, nitrosamines, synthetic and/or degradation impurities), including in silico assessment.
Benefits
  • Medical insurance;
  • Dental insurance;
  • Meal allowance;
  • On-site cafeteria;
  • Transportation allowance/shuttle/parking – depending on work location;
  • Pharmacy/dispensary with free medications for you, your parents, spouse and children;
  • Life insurance;
  • Private pension plan to help you plan your future;
  • Have children? You will be entitled to daycare (depending on work location);
  • Beauty salon so you can take care of yourself;
  • Gym to look after your health;
  • Short Friday to enjoy the day as you wish (6-hour workday for employees not working shifts);
  • Development programs offering partnerships with educational institutions at a discount;
  • Maternity leave;
  • Extended paternity leave.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
API synthesisevaluation of impurity profilesdevelopmentforced degradationstability studiesanalytical validationNitrosamine risk assessmentpreparation of SOPsdocumentation assessmentproject management
Soft Skills
negotiationcommunicationteam supportinterdepartmental collaborationorganizational skills
Certifications
Bachelor's degree in ChemistryBachelor's degree in PharmacyBachelor's degree in Chemical EngineeringMaster’s degree in Organic ChemistryPhD in Organic Chemistry