To attain challenging and responsible position, where I can enhance my skills and capabilities in consonance with the organizations Goals and objectives
Overview
24
24
years of professional experience
9
9
years of post-secondary education
2
2
Certifications
Work History
QC Head (DGM)
Dalas Biotech Ltd.
12.2024 - Current
Company Overview: WHO-GMP, ISO: 9001: 2008. Bhiwadi, Alwar Rajasthan.
As project team member of new Udaipur Plant project new Lab setup for API/Formulation (OSD) Plant for Dydrogesterone API and Formulation Plant.
New QC/Microbiological Lab with all Analytical instruments and Qualification done as per 21 CFR-Compliance for API and OSD Tablet Analysis.
Various national/international vendor Audits faced like. Welding Pharma (Germany); Pharmaid (Russia); QP Audit (UK Waymade); Pharmamaid (Russia); Popular Pharma(Bangladesh) and Nuvista Pharma Bangladesh; Alkem Laboratory etc.
GMP/WHO-GMP Approve unit.
Head of QC (AGM)
Mankind Pharma Limited.
07.2021 - 03.2023
Company Overview: WHO-GMP, USFDA, Approved unit.
WHO-GMP, USFDA, Approved unit.
Sr. QC Manager
Mankind Pharma Limited.
07.2019 - 06.2021
Company Overview: WHO-GMP, USFDA, Approved unit.
WHO-GMP, USFDA, Approved unit.
QC Manager
Mankind Pharma Limited.
07.2017 - 06.2019
Company Overview: WHO-GMP, USFDA, Approved unit.
Dydrogesterone (API) and Dydrogesterone Granules Formulation for direct Tablet Compression.
WHO-GMP, USFDA, Approved unit.
Q.C./Q.A. Manager
Pharmchem Ltd.
05.2007 - 03.2010
Company Overview: GMP/WHO-GMP Certified Company.
M/s Phamchem Ltd. is Manufacturing Mainly Erythromycin Group Bulk drug (API) and other products are Silver Sulphadiazene, Niacin, Niacinamide and Diclofinic Sodium.
GMP/WHO-GMP Certified Company.
Sr. QC/QA Manager
Dalas Biotech Ltd.
Bhiwad, Rajasthan
03.2010 - 06.2017
Company Overview: WHO-GMP, ISO: 9001: 2008. Bhiwadi, Alwar Rajasthan.
Company Overview: WHO-GMP. Boisar Tarapur, Maharashtra.
M/s. Auro Laboratories Ltd is Manufacturer of Bulk drug (API) of Chloroxazone (CRZ), Anilino Compound and Trimethoprim, Metformin HCL (COS certified).
WHO-GMP. Boisar Tarapur, Maharashtra.
Q.C. chemist
Life Line Beverages (P) Ltd
10.2001 - 05.2002
Packaged Drinking Water.
Education
Ph. D. - Chemistry
Jiwaji University
Gwalior
06.2002 - 05.2006
M. Sc. - Analytical Chemistry
Jiwaji University
Gwalior
01.1999 - 04.2001
B. Sc. - CBZ
Jiwaji University
Gwalior
01.1997 - 04.1999
Skills
Friendly, positive attitude
Certification
FDA Approval as Analytical Chemist, Haryana Drug Controller
Goals And Objective
To attain challenging and responsible position, where I can enhance my skills and capabilities in consonance with the organizations Goals and objectives
Key Results Area
Handling of departmental as team Leader of all sections (Stability, in-process, RM, FG, GLP, and QMS) with productivity and positive think, developed team member with internal anf external audits. compliance Training.
Resolve analytical instruments Tribal shooting, Preparation of SOP, STP and handling of Lab incident, OOS, OOT, OOC, Deviations, CAPA, SOP, SPC, STP, AMV, AMT, CV, Protocols, Qualification of Lab instrument system Audit Trails and review, and Excel Sheet validation etc.
Ensure to Comply the Quality of product as per current USP, B.P, & I.P Standard etc.
Sound Knowledge of ICH, EU, GXP, 21CFR Part-11 and their effective for Quality compliance.
Handled internal audit, national, international inspectors and their report preparation.
Involve in Analysis of all In-Process, RM, Excipient, FG, Stability, MLT and Water testing of physiochemical & Microbiological testing parameter.
I have handling and calibration experience of many analytical instrument as such UV/VIS spectrophotometer Simadzu1601, PerkinElmer and LabIndia 3000+, HPLC Shmiadzu, Water’s HPLC with Empower, GC-HS-GC PerkinElmer (Clarus-580), GC-HS Shimadzu 2010 plus, FTIR PrekinElmer (100 spectrum, spectrum-2), Rudolph Polarimiter; Electrolab instruments (Dissolution Apparatus, Friability, Leak tester, Disintegration Apparatus; Hardness Tester) DC Polarograph, Cyclic voltammeter, Coulometer, pH meter, Conductivity meter, Turbidity meter, Colorimeter, Potentiometer and Karl Fischer, etc.
Software Knowledge of Microsoft Office, SAP, Nichlon5, Caliber (QMS), Chromatographic Software (Empower, LC Solution, Lab solution) and all QC Lab Tools etc
Data interpitation of IR,NMR,Mass.
Publications
Synthesis and Electrochemical behaviour of 1-Ethyl-2-[4’-Sulphonamoylphenyl] Hydrazone-3-oxobutanoates., R. Jain, Virendra Kumar Arya, Ramji Yad, Shrinaryan Karaiya, JSIR, 72, 03/01/13, 160-165
Synthesis and Electrochemical behaviour of 2-[4’-(substituted) Sulphonamoylphenyl]azomethine indoles., R. Jain, Shrinaryan Karaiya, Ramji Yad, Virendra K Arya, JSIR, 71, 09/01/12, 606-611
Synthesis and Electrochemical behaviour of 2-[4’-(substituted) Sulphonamoylphenyl] Hydrazono ethyl-2-cynoethenoate., R. Jain, Ramji Yad, Shrinaryan Karaiya, Virendra K Arya, JSIR, 70, 09/01/11, 767-772