Manager Documentation
4 days ago
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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