Darshana Takale
About Candidate
API Regulatory affairs | Development Quality assurance | Module 3.2.S.4.1/2
Location
Education
M
M.Sc.
2009
SNDT University
Full time
Work & Experience
A
Assistant manager
Cipla ltd.
Assists with preparation of product development documents. Assists with preparation of regulatory submission documents (DMF module 3.2.S.4). Performs quality checks on DMF documents. Designs specification of Finished product intermediates, Active pharmaceutical ingredients, Intermediates and Raw materials in accordance to ICH guidelines and applicable pharmacopoeias. Communicate with Pharmacopoeial Forum for support of Monograph drafting for in-house molecules. Handling of Change requests.
