Sudeshna Mandal
Quality control - Glenmark Pharmaceutical Ltd.
- Role
- Quality Control-clinical Research and Pharmacokinetics at Glenmark Pharmaceuticals
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
Experience
Quality Control-clinical Research and Pharmacokinetics
Jul 2005 — Present · Mumbai, IN
Manage the development, organization, control and monitoring of Quality Control systems related to all Bioanalytical and clinical procedures (BA & BE Studies).*Audits of project documentation, in process phase, study reports as per regulatory guidelines.*Audit of documents related to validation of equipments and instruments.*Implementing of Quality Systems - preparation of SOPs and other documents, as per prevalent international guidelines.*Experience in US- FDA, ANVISA and GLP audits. Well versed with regulatory activities and clinical data management.
Education
Institute of Pharmaceutical Management, Mumbai
PG Diploma in Regulatory Affairs (Formulation)
2011 — 2012
Indian Institute of Technology (Banaras Hindu University), Varanasi
M.Tech, Biochemical Engg.
1998 — 2000
Birla Institute of Technology, Mesra
B.PHARM
1994 — 1998
Skills
- Microbiology
- Anda
- V&V
- Quality System
- Validation
- Quality Control Systems
- Gas Chromatography
- Pharmaceutical Industry
- Biotechnology
- Glp
- Bioanalysis
- Pharmaceutics
- Drug Delivery
- Laboratory
- 21 Cfr Part 11
- Fda
- Gmp
- U.s. Food and Drug Administration (Fda)
- Quality Control
- Sop
- Regulatory Affairs
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