1. SACHIN CHAVAN
203/Sirvi Complex, Plot no. 17, sector 21 Kamothe, Navi Mumbai.
Email- chavanssachin@rediffmail.com
Mobile No. 9821225087/8080765298
SUMMARY: M. Sc. with more than 9 years total experience including over 5 years
experience in QC dept.
EDUCATIONAL AND PROFESSIONAL QUALIFICATIONS:
M.Sc. in Chemistry from Madurai Kamaraj University. May 2011.
Bachelor of Science in Chemistry from Mumbai University (Passed May 2002), Guru
Nanak Khalsa College, Matunga.
REGULATORY EXPOSURES:
USFDA
Medicines Control Council, SA
MHRA
WHO
EMA
WORKING EXPERIENCE:
1. Working as Section Head in Bioclinical Departmentat SITEC LABS PVT. LTD., MUMBAI,
from Jan 2012 till Dec 2013.
Work Profile:
Conduction of various BA/BE studies such as oral dosages, inhalers, nasal
sprays, injectables and anti microbial for regulatory submission.
Preparation of SOP’s for the Data Management.
Coordinating with screening team for arrangement of screening and post studies
of volunteers for study.
Management of clinical staff for timely submission of documents.
Query resolution.
Preparation of regulatory inspections.
2. Worked as Team Leader in Quality Control department at SITEC LABS PVT. LTD.,
MUMBAI, from Jul 2006 to Jan 2012.
Work Profile:
Monitoring of BA/BE studies clinical part.
Responsible for quality conduct of the study in compliance with Protocol, GCP
regulatory requirements and relevant SOPs.
Review of clinical data.
Review of Statistical and final report of the study as per ICH E3 guideline or
regulatory requirements.
Preparation of regulatory inspections.

2. 3. Worked as Clinical Research Associate in SITEC LABS PVT. LTD., MUMBAI, from Dec
2004 to Jul 2006.
Work Profile:
Communication with the Sponsor & IEC members.
Preparation of Protocols, CRF & study related Documents for the Clinical studies.
Worked closely with Principal Investigators, Study co-ordinator and Bioclinical
Head and laboratory affiliate to assure the proper and successful conduction of
clinical phase of BA/BE studies.
Preparation of Clinical study reports for the submission of various National &
International Authorities.
Along with the study coordinator and clinical staff helps in preparing SOP’s,
EOP’s & IOP’s.
4. Worked as Clinical Research Associate in Medlar Laboratories Pvt. Ltd. from Jun 2004
to Dec 2004.
Work Profile:
Communication with the Sponsor & IEC members.
Preparation of Protocols, CRF & study related Documents for the Clinical studies.
Worked closely with Principal Investigators, Study co-ordinator and Bioclinical
Head and laboratory affiliate to assure the proper and successful conduction of
clinical phase of BA/BE studies.
Preparation of Clinical study reports for the submission of various National &
International Authorities.
Along with the study coordinator and clinical staff helps in preparing SOP’s,
EOP’s & IOP’s.
Training and Workshops Attended:
Attended workshop on “GCP & Independent Ethics Committee – Composition &
function” conducted by Academy for Clinical Excellence at Mumbai.
Attended training on GCP and GLP conducted in Cipla by Dr. Harold Neal, UK.
Attended training on GCP and GLP conducted in Cipla by Dr. Chin Yoke Yew, ICON
clinical research, Singapore.
Attended training on GCP and GLP conducted in Cipla by Dr. David Ford, UK.
Attended training on “Role of Independent Ethics Committee” conducted in Sitec by
DrPratibhaWorlikar.
Attended training on GCP and GLP conducted in Sitec by ACE.
Personal Details:
Languages Known- English, Marathi and Hindi.
Hobbies- Listening music, playing cricket.
Additional Qualification- Basic knowledge of computers.