Harsh Joshi
Head QA/QC at Deccan Fine Chemicals (India) Pvt Ltd
- Role
- General Manager at Ctx Lifesciences
- Location
- Surat, GJ, IN
- LinkedIn followers
- 500 followers
About Harsh Joshi
Employment History Deccan Fine Chemicals India Pvt Ltd- September 2017 as Head…
Experience
General Manager
May 2010 — Present · Surat, IN
Colourtex Group of companies was founded in the late sixties. CTX Lifesciences is an Active Pharmaceutical Ingredient (API) and intermediate manufacturing company, having a cGMP facility spreaded over 38 acres of land, USFDA, EDQM, EUGMP, KFDA,IRAN MOH and COFEPRES approval. The facilities are accredited by ISO 90••••08, ISO - 14•••••04, ISO 18•••••07, ETAD Member. Quality Control related activity :o Implementing innovative solutions to support and drive the changes through the Quality Control and Assurance regulations o Entire Control of the GLP Compliance with recruitment of result oriented, motivated and skilled workforce.o Technical support to execute stability studies as per ICH norms at development level and after commercialization for all ICH conditions and Brazil requirement inline with market simulated packing conditions.o Online Instruments calibrations, maintenance & qualifications, WS/RS maintenance and update, chemical wet laboratory maintenance with analyst validation.o Microbiological laboratory controls for water system validation and area monitoring with trend data preparation for water system, area monitoring and API bio-burden and bacterial endotoxin tests for non-sterile API.o Support for analytical method development and validation for cleaning methods, particle size method, related substance, assay etc by HPLC or other specified technique and polymorphism study using DSC and XRD. o Accustomed with sophisticated instruments for chromatography like HPLC, LCMS, Ion chromatography, GC/GCHS, GCMS, for spectroscopy FTIR, UV spectrophotometer, for thermal analysis and polymorphism study differential scanning calorimetric analysis, thermal gravimetric analysis, for material shape and size Particle size analysis by laser diffraction method, for morph related X-Ray diffraction analysis.
Education
Veer Narmad South Gujarat University
Ph.D
2001 — 2004
Atul - Kalyani Schoool and Bai Avabai-Valsad
Secondary and Higher Secondary
1983 — 1995
University of Pune
M.Sc
1999 — 2001
Sardar Patel University, Vallabh Vidhyanagar
B.Sc.
1996 — 1999
Skills
- Cleaning Validation
- Glp
- Hplc
- Analytical Chemistry
- Change Control
- Pharmaceutical Industry
- Sop
- Chemical Engineering
- Chemistry
- Gmp
- Chromatography
- Technology Transfer
- Quality System
- Validation
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