1. RESUME
Mr. PRADIP N. THAKARE
FUTURE PERSPECTIVE
“Seeking the challenging job in your organization to perform my skills and abilities that
ultimately participate in the growth of the organization”
PERSONAL DETAILS
TOTAL EXPERIENCE (5.6 Years)
• Currently working with Enaltec Labs R & D centre, Ambernath, Mumbai, as Sr.
Executive Clinical Support from Feb. 2014 till date.
• Working with Alkem Laboratory Pvt. Ltd. R & D centre, Taloja, Navi Mumbai, as
Research Associate Quality Assurance from Apr. 2012 till Feb.2014 (1 Years 10 Months)
• Worked with Inventia Healthcare Pvt. Ltd. Mumbai, as Production Officer from Aug.
2009 till Aug. 2010 (1 Year)
RESPONSIBILITIES
 Enaltec Labs (Getz Pharma Research Pvt. Ltd. R & D center)
 Position: Sr. Executive Clinical Support
• Conduct site qualification visit and evaluate the Quality Systems/Facilities and
Procedures of clinical research organizations (CRO) in compliance to GxP.
• Communicating with the CRO for regulatory application of study.
• Review of study documents like Protocol, ICF, CRF, method validation report, Bio-
analytical report etc.
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Present address
Contact details
E-mail
101, Building No. 02, Jainam Residency,
Shivmandir Road, Pale Shivar, Ambernath (E), Tal.
Ambernath, Dist. Thane, Maharashtra.
Mobile no: 07588736598, 9167684128
pradip.thakare1987@gmail.com
Marital Status Married
Languages Known English, Hindi and Marathi
(Read, Write, Speak)
Date of Birth 05th
Apr. 1987

2. Pradip N. Thakare- Resume
• Conducting Study monitoring visits at the CRO from initiation of the study to final close-
out at regular intervals for compliance to GxP.
• Preparation of CRO qualification audit reports and Study monitoring reports for the
audits and monitoring visits respectively.
• Review of Bio-analytical data.
• Verification of Corrective and Preventive Action (CAPA) of the response to the audit /
monitoring reports submitted by the CRO and discuss the same with head of the
department.
• Comparisons of the quotes obtained from different CROs and discuss the same with
head of the department and Business Development.
• Prepare / Review the Standard Operating Procedures (SOP) for the Clinical Support
Department.
 Alkem Laboratory Pvt. Ltd. R & D Centre
 Position: Research Associate Quality Assurance (1 Years 10 Months)
• Dossier Preparation
• Training Management system
• Audit of outsource study and CRO
• Preparation and review of Clinical Study Report (CSR)
• Bioequivalence Study (Clinical, Bio-analytical and Statistical) Compliance as ICH-GCP
• System Audit of different dept.
• Review of protocol
• Audit of Screening of volunteers
• Audit of dispensing of Investigational Product(IP)
• Auditing of Trial Master File(TMF)
• Calibration and Validation of equipment
 Inventia Healthcare Pvt. Ltd.
 Position: Production officer (1 Year)
• Preparation of Batch Manufacturing Record and Batch Packing Record
• Qualification and Calibration of Equipment/ Instruments
• Handling of Tablet compression machine, Capsule filling machine, tablet, Capsule
packing machine
• SOP preparation and training.
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3. Pradip N. Thakare- Resume
EDUCATION DETAILS
• Master of Pharmacy in Quality Assurance, in August 2012 from R. C. Patel Institute of
Pharmaceutical Education And Research, Shirpur Dist- Dhule, Maharashtra. (North
Maharashtra University, Jalgaon)
• Bachelor of Pharmacy (B. Pharm.) (North Maharashtra University, Jalgaon), in May
2009, from J. Z. M. D. S. College of Pharmacy, Jalgaon.
• Diploma in Pharmacy (D. Pharm.) in Sep. 2006 from R. C. Patel Institute of
Pharmaceutical Education And Research, Shirpur Dist- Dhule, Maharashtra.
• Registered Pharmacist, Maharashtra State Pharmacy Council.
PROJECT DETAILS
• BIOEQUIVALENCE STUDY OF AZATHIOPRINE TABLET USING LC/MS-MS
• PUBLICATION: In Journal of Pharmacy and Bioallide Science
Determination of Azathioprine in bulk and pharmaceutical dosage form by HPTLC
method
• PROFESSIONAL ACTIVITIES:
B. Pharmacy Project: In Production and Q.A. in Ethypharm Pharmaceutical. Ambernath
(2008-09)
COMPUTER KNOWLEDGE
• Windows operating systems and application software: MS Office, Scientific data retrieval
from Internet portals and Microsoft Excel, Microsoft Word etc.
• Good hands on Computer Operation, Internet, Excel, etc.
REFERENCES
• Will be provide if required
STRENGTHS:
• Don’t wait for an opportunity rather creates it
• Strongly believe in the inner goodness of an individual
• Believe in “Team work = Great Success”
• Confident, good orator – communicator
• Down to earth! I like to speak through my work!
I hereby solemnly, do affirm that the particulars furnished above are true to the best of my
knowledge.
Sincerely,
Mr. Pradip N. Thakare
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