Sandip Bhimani - CV - QA - Doc - 8.11 Years

CURRICULUM-VITAE
SANDIP H. BHIMANI
Mobile No.: +91 – 9662130807

E-mail: [email protected]
Job Objective
To attain a position where I could demonstrate my skills, knowledge, and creativity along with
proven ability to solve problems and meet challenging goals so as to become a valuable asset to
the organization.
Area of Interest
 QA – Documentation
 Regulatory Affairs
Education Qualification
Exam/Degree Board/University Institute/School Year % / CPI

M. Pharm Saurashtra University,
Department of Pharmaceutical
2011-2013 7.86 CPI
(DRA) Rajkot Sciences, Saurashtra University, Rajkot
Saurashtra University,
S.S. Institute of Pharmaceutical
B. Pharm 2007-2011 61.89 %
Rajkot Education & Research, Hadala, Rajkot
Smt. V.S. Shah Higher Secondary
Class XII GSHSEB, Gandhinagar 2007 57.80 %
School, Wankaner
Class X GSEB, Gandhinagar Shri K. K. Shah Madymaik Vidyalaya, 2005 76.14 %
Wankaner
Work Experience (Total 7+ Years)
1. Organization: Intas Pharmaceuticals Limited, Matoda Plant, Ahmedabad
Job Tenure: Dec. 2016 to till date

Designation: Executive Q. A.
Company Profile: Intas is a leading, vertically integrated global pharmaceutical

formulation development, and manufacturing company. Having approvals of USFDA,
MHRA, TGA, MCC, ANVISA, GCC.
Page 1 of 4
Key Duties:
 Preparation of Product Quality Review report and Continued Process Verification report.
 To Review Electronic Master Production and Control Record (Solid Orals).
 Creation and Revision of Bill of Material in SAP System.
 To review and handle Change Control.
 As a supportive role for RA department by providing required documents for
submission (ANDA Filing, Supplement Filing, Variation Filing).
 Distribution of Registration Transfer Document through PharmaReady software.
2. Organization: Orbit Pharmaceuticals, Ahmedabad, Gujarat.

Job Tenure: January 2015 to Dec. 2016
Designation: Executive Q. A.
Key Duties:
 Preparation of Standard Operating Procedures as per current regulatory requirements.
 Preparation and approval of raw material specification, in-process specifications and
finished products specification of products meeting the quality standard for their
intended use.
 Surveillance and implement of WHO GMP compliance activities within the
organization.
 Review and implementation of Batch Manufacturing Record and Batch Packing Record.
 Perform and implementation of QMS system within the organization, with electronic
QMS.
 Preparation & Performance of Qualification of Instruments and Equipments.
 Preparation of various protocol and report of Validation, Stability, Qualification, and
Sampling.
 To prepare Validation Master Plan, Site Master File and Annual Product Review.
 To perform internal audit timely and do the compliance of noted activity.
 To assist Formulation & Development department for the preparation of Product
Development Protocol & Report.
 Prepare and maintain appropriate internal and regulatory documentation, which is
subject to regulatory agency’s audit.
 To ensure and implement stability activity.
Page 2 of 4
3. Organization: Dupen Laboratories Private Limited, Vapi, Gujarat.
Job Tenure: January 2014 to January 2015
Designation: Chemist Q. A.
Key Duties:
 Maintenance of archival system (Receipt, issuance, retrieval and destruction of
documents)
 In process checks during manufacturing of intermediates and finished products.
 Prepare and maintain appropriate internal and regulatory documentation, which is
subject to audit.
 Issuance of formats as per concern department’s requirement.
 Issuance of Batch Manufacturing Record and Batch Packing Record. Review and
Maintenance of completed Batch Manufacturing Records.
 Management of Finished sample storage room.
 To assist in preparation of batch manufacturing records and Test Instruction/Test report.
Strength
 Reliable, highly energetic, adjustable to new environment, result oriented management
skills, persistent towards work and finishing tasks within deadlines as per the laid down
procedure.
Achievements
 Appointed as ISO Coordinator at Dupen Laboratories Pvt. Ltd. in addition to post of Q. A.
Chemist.
 Passed WIPO Distance Learning Course “General Course On Intellectual Property” during
November 2012 & April 2013.
Computer Skills
 Ms Office
 Internet skills
System Knowledge
 SAP
 Process XE (EBMR)
 QEdge
 PharmaReady
Page 3 of 4
Personal Details
 Date of birth : 02nd January 1990

 Father name : Mr. Hemantlal M. Bhimani
 Nationality : Indian
 Gender : Male
 Marital status : Married
 Languages known : English, Gujarati & Hindi
 Permanent address : Aalap Enclave, Block No. A/27, Near Yogeshwar Park,
University Road, Rajkot – 360005, Gujarat, India.
Declaration
I hereby declare that all the above details are true and genuine to best of my knowledge.
Place: Ahmedabad
Date:
Sandip H. Bhimani
Page 4 of 4

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CURRICULUM-VITAE

Mobile No.: +91 – 9662130807

Exam/Degree Board/University Institute/School Year % / CPI

Work Experience (Total 7+ Years)

1. Organization: Intas Pharmaceuticals Limited, Matoda Plant, Ahmedabad

Job Tenure: Dec. 2016 to till date

Company Profile: Intas is a leading, vertically integrated global pharmaceutical

2. Organization: Orbit Pharmaceuticals, Ahmedabad, Gujarat.

 Date of birth : 02nd January 1990

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