Sumit Gumasana is seeking a position that allows him to improve his knowledge and skills in accordance with industry trends. He has a B.Pharm degree and is currently working as a Senior Officer in CQA at Claris Otsuka Private Ltd, where his responsibilities include annual product quality review and overseeing the corporate quality management system. Previously he has worked as a Chemist in quality assurance roles at two other pharmaceutical companies, focusing on in-process quality checks, documentation, and investigation of issues. He has strong computer skills and experience adhering to various regulatory guidelines.

1. CURRICULUM VITAE
Mr. Sumit Gumasana Mobile No: +91 7567198308
B.pharm Email Id: psumit29@yahoo.com
Address: “Dwarika”
Shashtri Nagar Main Road
Gondal
Dist- Rajkot
State- Gujarat
OBJECTIVE
To associate with an organization, which dynamically gives me a chance to improve my
knowledge, upgrade my skills in accordance with latest trends and be a part of team that
vigorously works towards the organization.
AREA OF INTEREST
• QMS
• CQA
• IPQA
EDUCATIONAL QUALIFICTION
Sr.
No
Class School/college Board of
Passing
year
of Passing
% age
obtained
2 B. Pharm Agnihotri College of
Pharmacy, Wardha
Nagpur
University
2010 First Class
60%
3 H.S.C. Pathak School, Rajkot GSHSEB –
Gandhinagar
2006 Distinction
(72%)
4 S.S.C. Akshar Purushottam
Swaminarayan High
School
GSHSEB –
Gandhinagar
2004 Distinction
(72 %)
INDUSTRY EXPERIENCE
CURRENT: ( From December 2014 to Till date))
Currently working in Claris Otsuka Private Ltd. as a Sr.Officer CQA.
JOB PROFILE
Solely responsible for Annual Product Quality Review and Corporate QMS function. Roles
and responsibilities in detail as listed below.
• To collect and to organize the data from the batch manufacturing record and batch

2. packing records with its graphical execution, on quarterly basis.
• To collect and verify the starting material data, In Process Parameters Tests and
Finished Product tests from the Quality Control reports.
• To organize and verify the data related to Quality Assurance, Production,
Technical,
Engineering and International Regulatory Affair associated with all manufactured
product in the plant.
• To collect, review and organize the data related to Market complaint, Product
recall,
Phannacovigilance, Vendor, Adverse Drug Reaction/Events, Variations, Batch
failures records, Repacking, Returned Goods, Retain samples, Technical
Agreements, Periodic Safety Update Report submitted for product and Dispatch
details in the proposed calendar year.
• To conduct verification of Deviations, (CCN) Changes to Process or Analytical
methods, Out of Specification (OOS), Out of Trend (OOT), Stability Study results,
Adequacy of previous process or Equipment corrective actions, Qualification status
of equipments and Utilities, Validation carried out of the product as per the standard
operating procedure.
• To participate in change control impact assessment meeting and assess impact of
the
change on department and to inform assessment to manager. Also participate in
improvement trainings and Corrective Action and Preventive Action (CAPA)
meeting and review summary report of the same within defined time period
monthly.
• To track and provide the identified corrective actions to superior after review and
update oneself with current procedures across pharmaceuticals industry time to time
and if any change in Pharmacopoeia.
• To verify logbooks, online documents, records, analysis report and other
supporting
documents related to products manufactured in the plant.
• Participation in handling of Market Complaint and any Adverse Drug Reaction
from customer end.
• To prepare trends of all in process and finished products parameters through
Minitab software along with plenty types of statistical assessments.
• To follow-up with concerned departmental persons for rectifying issues during
analyzing and review of manufacturing records.
• To communicate and report the information to manager regarding the discrepancy
observed in the raw data collection for individual product from various departments
such as Quality Control, Production, Quality Assurance, Quality Management
System, Regulatory affairs, Stability Study etc.
• Time to time communicates with department head about any failure, abnormal
notification related- to quality of the products, regulatory observations and
responses during investigation for their attention and seeking for the solution.

3. • To determine the need for changes in drug product specifications or manufacturing
or control procedure and it is also provides instructions for the development of the
prodyct and includes direction for collecting, summarizing and reviewing of
parameters for Intra-batch and Inter-batch process variability and Process
Robustness as well as conclusions with recommendation.
• To ensure that the product meets the defined standards for strengths, identity, safety
purity and quality by various system-driven approaches.
• To elaborate understanding and application of schedule M, WHO GMP and
regulatory as well as semi regulatory guidelines such as United States Food & Drug
Administration (US-FDA), International Conference of Harmonization (ICH),
Therapeutic Goods Administration (TGA), National Health Surveillance Agency
(ANVISA), Medicines and Healthcare products Regulatory Agency (MHRA),
Pharmaceutical Inspection Co-operation Scheme (PIC/S) etc.
• To face all regulatory, semi regulatory and local audits. To be part of all internal
audits and go for cross functional inspections.
PREVIOUS: ( 8 Month)
Worked in Ratnamani Healthcare Pvt Ltd. in Quality Assurance Department as a
Chemist (Since Mar 2014 to November 2014)
JOB PROFILE
• In Process Quality Check for Compression of Tablets like
Friability,Wt.Variation,Disintegration,Hardness.
• In Process check for Primary Packing & secondary Packing of Tablet.
• Line Clearance at every step of batch manufacturing.
• Quality checking during Dispensing Activity.
• Documentation of calibration records,log books and temperature and humidity records.
PREVIOUS: ( 1.8 Years)
Worked in Concord Biotech Ltd, Ahmedabad as a Chemist Quality Assurance (Since
Jul 2012 to March 2014)
JOB PROFILE
• Responsible for issuance of BPR and other documents Format & Logbooks etc.
• Distribution & Retrieval of STP & SOP.
• Participation in OOS & OOT investigationt.
• Line Clearance for Dispensing Area.
• Quality check at time of Dispatch of FP.
EXTRACURRICULAR ACTIVITIES & HOBBIES
• Attened 60th
IPC in New Delhi-2008
• Playing Chess, watching movie, reading science related books.

4. COMPUTER SKILLS
• Well versed with Windows98/2000, windows XP, Windows7,Microsoft Office
(Microsoft Word, Microsoft Excel, Power Point),Internet and other basics of
Computer.
PERSONAL PROFILE
Name : Mr. Sumit Gumasana
Date of Birth : 14th
Sep 1989
Gender : Male.
Marital status : Single.
Language : English, Hindi, Gujarati, Marathi
Blood Group : B+ve
Email : psumit29@yahoo.com
Mobile No. : +91 7567198308
DECLARATION:
I hereby declare that the information given above is complete and correct to
the best of my knowledge and belief. I understand that I am liable to lose my lien on
the job, prior to or any time during employment, in the event of the above personal
information being proved false or incorrect.
Mr. Sumit N. Gumasana