Executive - F&D and ADL

2 - 6 years

2 - 5 Lacs

Posted:-1 days ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role Summary

ROW and US regulated markets

Role & responsibilities

  • Support formulation development of solid oral dosage forms (as applicable) for ROW and US markets.
  • Perform analytical method development, method transfer, and validation activities.
  • Conduct stability studies, dissolution profiling, and compatibility studies.
  • Prepare, review, and maintain development reports and technical documentation.
  • Support scale-up, technology transfer, and exhibit batch activities.
  • Assist in responding to regulatory queries and deficiency letters.
  • Ensure compliance with cGMP, GLP, data integrity, and laboratory SOPs.
  • Coordinate with QA, RA, production, and QC teams for project execution.

Preferred candidate profile

  • Hands-on experience in

    F&D and/or ADL

    functions.
  • Exposure to

    USFDA and ROW regulatory requirements

    .
  • Knowledge of method development, validation, and stability guidelines.
  • Familiarity with dissolution apparatus, HPLC, and analytical instruments.
  • Good documentation and data interpretation skills.

Qualification

  • M.Pharm / B.Pharm / M.Sc. (Pharmaceutical Sciences or relevant specialization)

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