Manager Documentation

1 week ago


Pune, Maharashtra, India Batavia Pharma Pvt Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

  • Review of Analytical Documents ( Method Development and Validation )and Data
  • Review of Method Development and Method transfer activities
  • Drug Formulations : Oral Solid Dosages, Liquid Orals, Semi-Solid and Injections.
  • Maintaining GDP and GLP documentation as per ICH guidelines w.r.t to product development method development, validation.
  • Finalization of Method Analysis, Specifications and Justification of Specifications.

Preferred candidate profile

  • Minimum of BSc in Chemistry / B Pharm or related field in life sciences required.
  • Experience with CGMP / CDMO sites.
  • Knowledge of and experience with the drug development process preferred
  • Experience with formulation development/drug product manufacturing service offerings preferred
  • Must possess excellent presentation, written, and verbal communications skills
  • Experience working for CDMOs preferred
  • Must be outgoing, energetic, self-motivated, and an organized team player and flexible in working.
  • Enjoy interacting with people, scientific discussions, and strategic thinking and planning
  • Must speak fluent English
  • Minimum experience of 10 years for review of documents as required by EU guidelines, candidate should have worked for EU markets.
  • Through knowledge of Analytical Chemistry , BP, USP and other ICH guidelines.


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