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Analytical Specialist- Formulation AR&D

  1. PSAI Global
  2. Hyderabad
  3. Formulation R&D - OSD

Job Description

  • Analyze critical API, excipient, and FP methods in R&D, and prepare verification reports to facilitate method transfer at the manufacturing site.
  • Core knowledge on Derma products, method development, and technology transfer is mandatory.
  • Perform elemental, genotoxic, and nitrosamine impurity assessments.
  • Develop and validate residue analytical methods.
  • Prepare technical justification reports in consultation with an expert.
  • Execute experiments to finalize critical methods and prepare method design and development reports.
  • Identify and ensure the availability of prerequisites like columns, chemicals, impurities, and standards for AMT at partner sites
  • Prepare specification, STPs, Justification and technical reports for the assigned products
  • Understand regulatory requirements specific to all regulated markets.
  • Knowledge on drafting the responses to regulatory queries.
  • Conversant with all pharmacopeias and guidelines.
  • Identify new technologies for project-specific challenges
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Additional Information

  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Ability to work collaboratively with own team and cross-functional teams.

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