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Batavia Pharma Pvt Ltd
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Manager Documentation

Manager Documentation

Batavia Pharma Pvt Ltd

12 - 18 years

|

8 - 9 Lacs

Posted:1 day ago| Platform:

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Skills Required

review of analytical documents analytical method validation analytical method development justification of specs analytical method transfer

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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Batavia Pharma Pvt Ltd

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