Pranjal Ojasbhai Dave is seeking a position in regulatory affairs or quality assurance where he can contribute his 2 years of experience as an auditor in clinical research. He has a M.Pharm in Quality Assurance and specialized knowledge of GCP, GLP, analytical method validation, and quality control tests. His objective is to intellectually and professionally develop by being part of an esteemed organization.

1. PRANJAL OJASBHAI DAVE
(M.Pharm, Quality Assurance)
Contact: +919879541651
Email: pranjal_dave@yahoo.in
OBJECTIVE
Seeking an opportunity to be a part of an esteemed organization and contribute my research skills and
specialized knowledge to its success and thereby nurturing myself intellectually and professionally.
AREA OF INTEREST
• Regulatory Affairs
• Quality Assurance
PROFESSIONAL EXPERIENCE
• Having 2 years of experience as an Auditor (Research Associate) in Veeda Clinical Research
Pvt. Ltd. Ahmedabad, India (Date of joining: 01 Apr 2013)
• Consistent and quality output of work done with adhering to the given time line for task with
continuous learning and development.
• M.Pharm (Quality Assurance) from PARUL INSTITUTE of PHARMACY, BARODA and Graduation
from SHRI SARVAJANIK PHARMACY COLLEGE, MEHSANA.
WORK EXPERIENCE
VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD Apr 2013- till date
Auditor (Research Associate), Quality Assurance
 Preparing study audit plan for BA/BE and Phase I studies
 Conducting study audits (In-Process audit and Retrospective audits) of Clinical as well as
Bioanalytical phase according to the audit plan.
 Preparation & Issue of study audit reports (In-Process and Retrospective audits) for Clinical &
Bioanalytical phase and their compliance verification till resolution.
 Review of Bioanalytical Study Plan, Method Validation Protocol, Method SOP & Final/Draft study
reports.
 QA compliance status verification and Issuance of QA Authentication for Study.
 Conducting System Audit
 Performing pre regulatory inspections/visit of clinical as well as Bioanlaytical facility.
 Understanding of the basic concept of Equipment Qualification, Deviations and CAPA, Change
control procedures
1

2.  Conducting Vendor Audit
MAAN PHARMACEUTICAL LIMITED, MEHSANA
QUALITY ASSURANCE CHEMIST
 Routine In process check
 Batch dispensing
 Packaging material approval
 Document review
 Retain sample collection
FORTE
 Aware about Good Clinical Practices in conducting clinical studies & Good Manufacturing practices
for Investigational medicinal products
 Detailed knowledge and clear concept of Analytical/Bioanalytical Method Validation
 Understanding of concept of Equipment Qualification, Change control, Deviation and CAPA.
 Ability to work with the consistency within stipulated time.
 Ability to work individually as well as in team
 Good communication skills
EDUCATIONAL CREDENTIALS
Qualification College/University
Year of
passing
Percentage
M. Pharm
PARUL INSTITUTE of
PHARMACY
Gujarat Technological
University
2012
CPI 7.80
(distinction)
B.Pharm
SHRI SARVAJANIK
PHARMCY COLLEGE
Hemchandracharya North
Gujarat University
2010 62.4%
M.Pharm Project - “ANALYTICAL, DISSOLUTION AND STABILITY INDICATING METHOD
DEVELOPMENT WITH VALIDATION FOR ESTIMATION OF AN ANTIEPILEPTIC DRUG BY
HPLC”
INDUSTRIAL TRAINING
• Completed six month of training from TORRENT RESEARCH CENTRE, BHAT
1

3. TRAINING AND WORKSHOPS ATTENDED
• External Training on “Good Clinical Practice” by Veeda Clinical Research Pvt. Ltd..
• External training on “ Good Laboratory Practices (GLP)” by Veeda Clinical Research Pvt. Ltd.
INSTRUMENTAL COVERAGE AND SKILLS
• Have thorough knowledge of practical and theoretical aspects of dissolution testing, UV visible
spectrophotometry, HPLC.
• Have basic understanding of principles of “GOOD MANUFACTURING PRACTICES” and Routine
Quality control tests
PERSONAL VITAE
Father’s Name: Dr. Ojasbhai Vasudevbhai Dave
Date of Birth: 18/08/1988
Marital Status: Married
Languages Known: English, Hindi & Gujarati
Address: A/102, Shetrunjay Residency, Behind Anandnagar Bus stop, Anandnagar,
Ahmedabad
DECLARATION
I hereby declare that the information furnished above is true to the best of my knowledge.
Place: (Pranjal Dave)
Date:
1