R RAJKUMAR JHA

Position: General Manager Technical

Company: ADLEY FORMULATIONS PVT. LTD.
Location: Sikkim, India
Experience: 22 years exp

Cont act Inf o:

Email: jharajkumar6911@rediffmail.com

Social:

Skills
21 CFR Part 11 Analytical Chemistry ANDA Approved Technical Person For CHEMICAL & INSTRUMENTAL

AS WELL AS MICROBIOLOGICAL TESTING Auditing By FDA MAHARASHTRA THANE CAPA Change Control

Cleaning Validation Continuous Improvement Deviations Environmental Management Systems FDA

Formulation Generic Programming GLP GMP HPLC ISO ISO 9001

Laboratory Information Management System (LIMS) Laboratory Skills Manufacturing Operations

Manufacturing Operations Management Manufacturing Process Improvement Pharmaceutical Industry

Pharmaceutical Plants Operations Pharmaceuticals formulation Plant Operations Quality Assurance

Quality Auditing Quality Control Quality Improvement Quality Management Quality System

Regulatory Affairs Regulatory Requirements Regulatory Submissions Software Quality Assurance Sop

Technology Transfer V&V Validation Water Quality

Work experience
Mar 2024 - current time General Manager Technical
ADLEY FORMULATIONS PVT. LTD.
Overall responsible for Productivity with Quality
Feb 2024 - current time Quality Head
Maxtar Bio-Genics
Skills: Manufacturing Operations · Pharmaceutical Plants Operations ·
Manufacturing Operations Management · Formulation · Auditing · Water Quality ·
Environmental Management Systems · Continuous Improvement · Quality
Improvement
Jan 2021 - Jan 2024 Site Quality Head
Alembic Pharmaceuticals Limited
Skills: Analytical Chemistry · Manufacturing Operations · Manufacturing
Operations Management · Formulation · Auditing · Quality Management · Water
Quality · Environmental Management Systems · Continuous Improvement ·
Quality Improvement
Jan 2021 - Jan 2024 Site Quality Head
Alembic Pharmaceuticals Limited
Skills: Manufacturing Operations · Manufacturing Operations Management ·
Software Quality Assurance · Formulation · Auditing · Quality Management ·
Water Quality · Environmental Management Systems · Continuous Improvement ·
Quality Improvement
Mar 2018 - Jan 2021 Site QA HEAD
Aristo Pharmaceuticals Pvt. Ltd.
Over all responsible for execution of QMS at SITE
Jun 2012 - Mar 2018 Site. Quality Head
Ipca Laboratories ltd.
Responsible for execution of QMS system as per cGMP, cGLP & cGDP, cGWP
May 2012 - Jun 2012 QA/QC head
Life Line Pharma
Overall responsible for QMS execution
Oct 2009 - May 2012 Head Of Quality
SUN PHARMA SIKKIM
Managing to maintain the Quality of Product formulated at our Plant by
implementation and continuous review of existing cGMP concept along with Gap
Analysis followed by identification and execution of CAPA to upgrade the
Quality system.
Feb 2007 - Oct 2009 Dy. Manager - QA
AKUMS DRUGS & PHARMACEUTICALS LTD
Handling of SOP,BMR & BPR, Quality system, Change Control, Deviation, IPQA ,
APR, Self Inspection & Quality Audit, Market Complaint,managed for successfull
audit and further WHO cGMP & ISO certification for our Injectable Plant along
with several third party audits of Giant Pharma manufacturers.
Jan 2006 - Jan 2007 Head QA
Creative health Care Pvt. Ltd
Over all responsible to maintain the Quality of Product being formulated at our

Jan 2004 - Jan 2006
Mar 2003 - Jul 2004
Plant followed by Handling of SOP,BMR & BPR, Quality system, Change Control,
Deviation, IPQA , APR, Self Inspection & Quality Audit, Market
Complaint,managed for successfull audit of several third party audits of Pharma
Companies like CIPLA, Glenmark etc.
Head Quality
Lesanto laboratories
Over all responsible to maintain the Quality of Product being formulated at our
Plant followed by Handling of SOP,BMR & BPR, Quality system, Change Control,
Deviation, IPQA , APR, Self Inspection & Quality Audit, Market
Complaint,managed for successfull audit and further WHO cGMP Certification
for our Plant along with several third party audits of Pharma Exporters.
QA MANAGER
Ronilo Pharma Pvt. ltd.
Over all responsible to maintain the Quality of Product being formulated at our
Plant followed by Handling of SOP,BMR & BPR, Quality system, Change Control,
Deviation, IPQA , APR, Self Inspection & Quality Audit, Market
Complaint,managed for successfull audit faced several third party audits of
Pharma Exporters.

Educat ion
1990 - 1992 CHEMISTRY WITH SPECILISATION IN PHYSICAL CHEMISTRY
MASTER OF SCIENCE
B.N.MANDAL UNIVERSITY MADHEPURA, BIHAR
1990 - 1992 Chemistry
Master of Science - MS
BNM University Mafhepura
1987 - 1990 CHEMISRTY(HONOURSE) WITH BOTANY & Z OOLOGY
BATCHELOR OF SCIENCE
BHAGALPUR UNIVERSITY, BHAGALPUR

Head line
Plant Operations

Summary
I have Educational, technical & managerial experience and sound knowledge for heading QC,QA,
Regulatory,Operational activity of Pharmaceutical Manufacturing company either jointly. Well experienced in OSD,
Liquid, External Preparation, SVP, LVP,PFS. Dry Powders, Sterile n No sterile both types formulations Plant.

Languages
Marathi,Gujarati,

Project s
lab set up at various previous organisation

Cert if icat ions

Approved Technical Person for Chemical, instrumental & Microbiological Testing from FDA Thane MAharashtra