Varsha Kshirsagar
Sr. Manager RA
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About
Well versed with Regulated / Semi-regulated markets (ACTD / CTD), filing, registrations. Country specific Dossier preparation and compilation of various countries like CIS, Asian and African countries. Well aware of Guidelines like Drugs Act, GMP, GLP, ICH, compendia requirement for products, processes, facilities, utilities and analysis.
Well aware with Licensing (both state FDA and CDSCO), QMS and compendia requirements for Tablets, Capsules, Injectable: LVPs and SVPs and Oncology, etc. Oversee the laboratory for GMP/GLP and safety compliance. Co-ordination with QA-QC, Production team and review technical documents.
Review, approve or reject and release product. Coordinating with QC-Production and other dept. for validation, qualification of instrument/equipment machineries. To assist the internal/external audits and give compliances.
Hands on experience of analytical techniques, sophisticated instruments, Microbiological assay.
Experience
Sr. Manager RA - ZEST Pharma Indore - Indore
(2023-03)
Sr. Manager QA and QC - Bio vaccines (India) Pvt. Ltd. - Indore
(2020-01 - 2023-02)
Administrator of QA and QC - S.A. Herbals Bioactive LLP - Pithampur
(2019-01 - 2019-11)
Asst. Manager Regulatory Affairs - Parenteral Drugs (India) Limited - Indore
(2005-10 - 2019-01)
Executive - Plethico Pharmaceuticals Limited - Indore
(1992-12 - 2005-09)
Education
Ph.D. - Chemistry
Post Graduate - Organic Chemistry
Graduate - Physics, Chemistry and Biology
