1. Kamal Jeet Singh
H.No # 1355, Sector
21,
Panchkula (Haryana) -134112
Phone: 09780805924, 9805380989
Email: kamaljeetsingh82@rediffmail.com
Kamaljeetsingh82@gmail.com
ACADEMIC QUALIFICATIONS
MSc. Chemistry, 2003-2005, Guru Jambheshwar University, Hisar
(‘A’ Grade university Accredited by NAAC)
Overall percentage – 61.0%
BSc. (Non-Med.), 2000-2003, Kurukshetra university, Kurukshetra
Overall percentage – 67.0%
WORK EXPERIENCE
Reckitt Benckiser Healthcare (India) Ltd., Baddi (H.P), Executive Feb 2014 – Present
RANBAXY Laboratories Ltd., Pharma Mfg. Mohali, (Pb.), Executive June 2010 – Feb 2014
R&D, Lalru (Pb.), Executive (Stability) Nov. 2008 – June 2010
Pharmaceuticals Ltd, Baddi, (H.P) Executive, Quality Control, July 2005 – Nov. 2008
CURRENT JOB PROFILE – Executive, QC, Reckitt Benckiser Healthcare (India) Ltd., Baddi (H.P)
Functional Area: QA Lead – Documentation, Release & QMS
Handling of Deviation Management and Change Management in line with respective procedures and policies.
Handling of Change Management.
Handling of Failure Investigation and suggesting CAPA & closure of CAPA related to general observation and
audit observation.
Documentation control.( Review and Approval of Master documents)
Batch Release in SAP.
Review of Master Batch Manufacturing/Packaging documents.
Trending of deviations and effectiveness check.
Preparation of weekly, monthly reports and conduct monthly reviews at plant level.
Documentation control (Review and Approval of Master documents). Track retrieval of master documents and
issuance of control copies.
Conducting Internal Audit
Key user for QM module of SAP at site, responsible for preparing inspection plan, quality view and providing
assistance for SAP issues during routine operation
2. Quality compliance at the shop floor supervising the entire IPQA team
Deviation for the noncompliance observed during AQL and getting its CAPA and ensure closure before releasing
Upgrading of SOP’s according to current regulations and simplification of procedures.
Conducting training session on the departmental procedures and awareness trainings of various incidences
related day to day working.
Audits faced: USFDA, MHR
PREVIOUS JOB PROFILE – Executive, QC, Ranbaxy Laboratories Ltd., Pharma Mfg., Mohali (Punjab)
Functional Area: Reviewer Finish Product / Raw Material Section
Review of analytical data of finish product and raw material.
Daily work & shift planning and monthly output report preparation.
Conducting Primary Laboratory Investigations & root cause identification during OOS.
Performing investigations of incidences associated to non compliance in laboratory. Establishing CAPA and
CAPA effectiveness.
Conducting awareness and on hand training to new employees about the SOP’s of laboratory and instrument
operation.
Providing assistance in compliance related to Audit observation, if any.
Audits faced: USFDA, MCC, ANVISA, WHO, Health Canada.
Providing new ideas for better reliable, compliant, lucid way for representation & recording of analytical data
like preparation of product preprinted data sheets.
Preparation & execution of instrument qualification document. Have experience of installing and working of
AAS, GC (Perkin Elmer & Agilent), HPLC (Waters & Agilent), UPLC (Make: Waters), Gas generators, Malvern
particle seizer, control sample chamber, dissolution (Distek & Electrolab), UV/Visible (Perkin Elmer).
Preparation of SOP’s related to Quality control activities and instrument operations.
Preparation of instrument temperature mapping protocols for refrigerator, Chambers, LOD / Vacuum ovens,
Muffle Furnace.
Raising change control request for proposed changes in instruments, lab area etc.
Preparation & reviewing compliance of yearly calibration and preventive maintenance calendar
PREVIOUS JOB PROFILE – Executive, Stability, Panacea Biotec Ltd. Lalru (Punjab)
Functional Area: Stability Study Section
Monitoring of stability samples as per guidelines. And generate the data & CoA by LIMS
Monitoring of stability chambers
Providing suggestions with support if any, for change in analytical method of testing which otherwise is not
justifying the test results.
Calibration of HPLC, UV, Dissolution Test Apparatus.
Providing Inputs during internal and external audits.
Working in environment, which follows GLP.
Knowledge of cGMP’S.
Routine Documentation.
Handling and testing of stability samples as per WHO & ICH guidelines.
3. PREVIOUS JOB PROFILE – Executive, QC, Torrent Pharmaceuticals Ltd. Baddi, (H.P)
MAIN FUNCTIONAL AREA
Functional Area: Finish Product section (Quality Control)
Details: In this section of quality control testing of inprocess, intermediate, semi-finished and finished pharmaceutical
products is carried out adopting most reliable and advance technique. The instrument which are being
operated by us while carrying out the mentioned activities are:
High Performance Liquid Chromatography.
UV/Visible Spectrophotometer.
FTIR Spectrophotometer.
Dissolution Test Apparatus.
Disintegration Test Apparatus.
KF Titrator
Tapped density apparatus, Brookfield viscometer, Tablet Hardness Tester etc.
Functional Area: Documentation and Calibration section (Quality Control)
Details: Documentation and calibration section of quality control deals in:
The preparation, maintenance and regular review and updating of all kinds of documents of general working
and regulatory importance.
Calibration and maintenance of records of all the instruments in the laboratory.
Preparation and review standard operating procedures under the guidance of the section head.
Installation and Qualification of Instruments: Some major instrument whose qualification is performed are
a. Walk In Humidity Chamber
b. Walk In Cold Room
c. Weighing Balance
Cleaning Method Validation using HPLC.
Intra departmental and sectional issuance and retrieval of various documents and records is also taken care
off.
Calibration includes in house and outside party calibration of instruments, preparation of calibration schedule
and re-qualification of instrument upon any break down.
Audits: ISO 17025:2005 (NABL), Preparation and compliance of quality Manual, Procedures & Formats.
OTHER FUCTIONAL AREA
Functional Area: Stability Section
Details: 1. Performing testing of stability samples and preparation of stability test summary reports.
2. Monitoring of stability chambers.
Functional Area: Working standard, reference standard & Impurities.
Details: 1. Preparation of Working standards & in house reference standards.
2. Procurement & issuance of pharmacopoeial reference standards & reference impurities
3. Check for change in lot number of pharmacopoeial reference standards & reference impurities.
Functional Area: SAP
Details: SAP is presently the most effective software used by all reputed companies. This software ensures that there
4. is secure and smooth movement of data in step wise manner from on stage to another taking care that there
can be no manipulation of data in future or by any other person.
I have been given opportunity by my present company to be a part of SAP validation core team and validate
the quality module of SAP. The validation included the testing of the entire user ID’s of quality control for there
authorizations and ensuring that the software is enough full proof in case any deliberate change is made.
Functional Area: Budget preparation and inventory management
Details: 1. Annual budget preparation of the department.
2. Maintenance and keeping a check on the chemical, glassware and lab consumables stock so that there are
no bottlenecks situations.
COMPUTER SKILLS
Course done : 1 year diploma in computers.
Languages : C/C++
Platforms : Windows 9x/NT/XP
Softwares : Microsoft Office- Excel, Word, Access, SAP, Stability software
Typing Speed : 35 w.p.m
PERSONAL DETAILS
Date of Birth : 20th
March 1982
Permanent Address: H.No.350, Sector 20, Sirsa
Nationality : Indian
Gender : Male
Marital Status : Married
Language Known : Hindi, English