Highly Skilled Analytical Professional

Há 13 horas


Brasil Healthcare Businesswomen's Association Tempo inteiro

At the Healthcare Businesswomen's Association, we are seeking a highly skilled analytical professional to join our team. The successful candidate will be responsible for implementing national and international standards and guidelines for analytical method validation and forced degradation studies.

Key Responsibilities:

  • Support the implementation of national and international standards and guidelines for analytical method validation and forced degradation studies.
  • Execute method validation and transfer activities for finished products according to current local and international guidelines.
  • Responsible for activities related to analytical worksheets, protocols, and reports (elaboration and revision), statistical analysis application for analytical method validation, and calculation of samples and analytical materials.
  • Support and handle technical discussions with global AS&T, manufacturing sites, ESO, TRD, Regulatory Affairs, Project Managers, and Third-Party Laboratories.
  • Collaborate in internal and external audits related to AS&T and QC and establish CAPA plans for findings.
  • Collaborate and provide technical support in case of deficiency letters raised by Health Authorities regarding AS&T topics.
  • Support and conduct analytical investigation activities according to demand, in compliance with local and global procedures.

Requirements:

  • A bachelor's degree related to the Pharmaceutical area, Chemical, or Biological, titled with a professional license.
  • 5+ years of experience in Pharma/Manufacturing sector in analytical labs.
  • Experience in the Pharmaceutical Industry, Development, and Analytical Method Validation.
  • Solid knowledge in Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and GDocP.
  • Statistical knowledge for the evaluation of analytical results.
  • Knowledge in current pharmacopoeias such as USP, EP, BP, JP, etc., local and international requirements.
  • Fluent in English.

Salary: $80,000 - $110,000 per annum, depending on qualifications and experience.



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