Deepak Nikam
Vice President - Analytical Development (OSD & API) and Quality Control (OSD) at Harman Finochem Ltd.
- Role
- Vice President - Analytical Development (Osd, Api) & Quality Control (Osd) at Harman Finochem Ltd
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Deepak Nikam
Pharma professional with 27 years of experience in Analytical Development and Quality…
Experience
Vice President - Analytical Development (Osd, Api) & Quality Control (Osd)
Sep 2018 — Present
Heading Quality Control Department for Solid Orals- Heading Analytical Development for Solid Orals and API- Heading Development Quality Assurance functions for API R&D and Formulation R&D- Implementing novel analytical development approach to improve output and quality- To guide the team for development of Short run, Robust methods with optimal use of UPLC, Fast LC- To guide the team for Development of Mass Spectroscopy methods for GTI and Nitrosamine impurities- Implementation of Quality Management systems such Change Control, Document Management System, Training module, CAPA management, LIMS, SAP etc- Deformulation/Reverse engineering for formulations- To lead OOS, OOT investigations and Other laboratory, non-laboratory investigations- To define testing, control and compliance strategy for Genotoxic impurities and Nitrosamine impurities- Setting limits for Organic impurities, Genotoxic impurities and Nitrosamine impurities- Monitoring Capex and Opex for 5 laboratories in Harman- Project planning and costing- Training and mentoring of subordinates, identifying development needs to upgrade individual skill sets- New analytical laboratory setup in 2019 and 2022- Implementation of Electronic signatures, custom field calculations for chromatographic analysis- Successfully faced US, EU, TGA and WHO audits.
Education
University of Mumbai
Master's Degree
2011 — 2014
University of Mumbai
Doctor of Philosophy - PhD
2016 — 2022
University of Mumbai
Bachelor's Degree
1993 — 1996
University of Mumbai
PGDTAC
1996 — 1997
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.