Mr.

B Parmar

 Completed Master of Pharmacy from B.N. College of Pharmacy, Rajasthan

University of Health Science in 2010.
 Well versed with GAMP-5, USFDA, PICs, cGMP, schedule M and 21 CFR 211
guidelines.
 Believe in continuous learning and an innovative approach.

SCHOLASTICS

2013 Diploma in Drug regulatory affairs from Bio-informatics Institute of India,

Noida. Secured 67%
2010 Master of Pharmacy – Pharmacology from B.N. College of Pharmacy,
Rajasthan University of Health Science. Secured 69%

2007 Bachelor of Pharmacy from G.R.Y. Institute of Pharmacy, Khargone

M.P. University. Secured 64%

2001 Higher Secondary Certificate (XII Std.) from Saraswati vidhya mandir,
Ujjain M.P. Board. Secured 64%

1999 Senior Secondary Certificate (X Std.) from Govt. high secondary school,
Unhel, M.P. Board. Secured 69%

Achievement

 Got the Appreciation letter from DR. Reddy’s Laboratories Limited over MHRA CAPA
compliance on “cleaning validation based on the hazardous molecule”.
 Two times rewards point earned from DR. Reddy’s Laboratories Limited over US E-
pedigree serialization Project.
 Three times Best Kiazen Award across Unit of Dr. Reddys Laboratories.

WORK EXPERIENCE

 Total 8.4 years experience

 Presently working in Freyr Software Services in Computer system validation

department at Hyderabad. Since 13 Aug 2018 till date.

 Three and half years of experience in quality assurance (CSV) department as

Assistant Manager at Dr. Reddys Laboratories Limited, Hyderabad since 16 Feb
2015 to 10 Aug 2018.

 Two years experience in quality assurance department (Process & cleaning

validation) at Ipca Laboratories Limited, Pithampur from 14 Jan 2013 to 06 Dec
2014.

 One year experience in quality assurance department (validation) as QA chemist at

P. D. I. L., Indore from 23 Jan 2012 to 29 Nov 2012.

 1 year and 6 month teaching experience as assistant professor from Smriti College of
pharmaceutical education, Indore from 10 Aug 2010 to 30 Jan 2012.
PROJECT HANDLED

 US E-pedgree serialization to make parent-child relationship between unique serial

no of carton and SSCC code of secondary shipper.
 EU E-pedgree serialization to make parent-child relationship between unique serial no
of carton and SSCC code of secondary shipper.
 Track and trace system for Auto-transfer of shipper from packing line to warehouse
for palatalization and storage.
 Automation of Solvent transfer system from bulk storage tank to the process area
with employment of SCADA system.
 Data acquisition system qualification for acquiring process data from various
equipment.
 Sleep mode and switch off mode project of Air handling unit to conserve energy by
reducing frequency of blower.
 Automation of the cleaning process using WIP system.
 Cleaning validation programme on health based exposure limit using ADE/PDE
values.

KNOWLEDGE PURVIEW

Computer System Validation (ITQA):

 Experience in validation of customized software.
 Computer System (Server & Client) qualification.
 Software verification and validation as per GxP, GAMP.
 Architecture and network qualification.
 GXP assessment and GAMP categorization.
 Electronic Record and electronic signature capabilities assessment.
 21 CFR part 11 and EU annex-11 assessment.
 Review and approve validation deliverable (Software & Hardware) and applicable
procedures. (URS, Validation Plan, IQ, OQ, PQ scripts, Trace-ability Matrix, Test
Summary Report and Validation Summary Reports,
 Familiar with Software development Life Cycle Model (‘V’ model).
 Review of software development document such as code review documents, Module
(unit) Testing documents, Integration Testing, Penetration Testing, ERES assessment
testing etc.
 Identify and Categorize software defect and track them through initiating the CAPA
for their closure.
 Supplier assessment as per GAMP-5 though the postal or on site auditing them for
their competency for development of software.
 Identify and Categorize software defect and track them through initiating the CAPA
for their closure.

Validation & Qualification Techniques:

 Execution of Installation, Operational and performance Qualification of various
equipment and instruments. (RMG, Blender, Compression machine, FBD/FBE,
Coating machine etc)
 Compressed air validation.
 Water (WFI, PW, PSG) system qualification and validation.
 Heating ventilation and air conditioning system validation
 Media fill validation
 Autoclave validation
 Tunnel validation
 Hot air oven validation
 Protocol and report preparation of Hold time study, cleaning validation, packing
process validation.
 Calibration of temperature sensor, pressure gauges and other instruments).
 Protocol and report preparation (IQ, OQ and PQ).

Process Validation and cleaning validation skill:-

 Process Validation (Solid Dosage form), continue process verification.
 Stratified sampling at blending and compression stage.
 Pre-validation batch challenge study execution.
 Review and approval of cleaning validation protocol and report.
 Review and approval of cleaning matrix.
 Review and approve the clean equipment hold time and dirty equipment hold time
study document.
 Participate in transition of MACO value calculation from dose based to toxicity based.
 Review and approve the visual inspector qualification and recovery study.
 Review of periodic assessment documents for cleaning verification study.
 Analytical Results review.

Quality management system

 Review, approval and closure of change control through the SAP system.
 Investigation, Review, approval and closure of incident through SAP system
 Quality risk management handling.

Participation in Audit facing

 USFDA, MHRA, WHO and INVIMA

POSTER AND PUBLICATION

 Poster presentation and publication in 61 st Indian Pharmaceutical Congress

Ahmedabad 2009 on “Effect of asparagus racemosus in arterio-venous shunt
thrombosis”.
 Participated in National Conference on Recent Trends of research in Pharmaceutical
sciences-08, Nathdwara, Rajasthan.

PROJECTS / INTERNSHIPS UNDERTAKEN

B. Pharma Project: - Project done on topic “Tobacco a world capturing product”

M. Pharma project:- The study has been undertaken with following objectives from
C.D.R.I., Lucknow
 To assess the anti-thrombotic potential of nitric oxide in rat AV Shunt model.
 To explore the cytokine profile and cell cycle modulation by NO donor treated HL-60
Cell line so as to assess the effect of NO on cell cycle.

IT FORTE

 Computer basic course (MS Window, Photoshop etc.) and Internet Browsing from
NIIT, Udaipur.
 C, C++, Java.
 Well versed with Statistics software like Origin, Prism, End notes.

PERSONAL DOSSIER

Date of Birth: 26/11/1984

Languages known: English, Hindi, Rajasthani
Marital status Married
Present address Chandanagar,
Hyderabad