1. Hitesh Maheshbhai Patel
B.Pharm, Ms. (pharmaceutical science, U.K.)
Permanent Address:- 2,Nagaraj Bungalows, Near ashvamegh Bunglows,
Near Shukan chowkadi, nava naroda,Ahmedabad -382346
Mobile no:- 9714804040,9427959258,9662061856
Email id:- jethitesh@yahoo.com
Objective:-
An extensive knowledge and versatile dynamism are praised with employment history as
professionalismin Quality Assurance & Quality Control process, which are deliberately able to imply
to be part of an organisation.
Professional qualification:-
Qualification Year of
Passing
Board/University Percentage Class
Master of
Pharmaceutical Science
2010 Universityof Greenwich
(U.K)
M Master
awarded
B.Pharma. 2008 RajivGandhi University Of
Healthscience,Banglore
71% First
H.S.C. 2004 G.S.H.E.B. 60% Second
S.S.C. 2002 G.S.H.E.B. 73.14% Distinction
Organization Experience:-
 Total experience 3.11 years in Pharmaceutical industries in Parenteral division.
 During my job, I had faced many successful audits like INVIMA and NDA and ANVISA.
 Presently, I am working in FAMYCARE LTD, Ahmedabad at Pharmez, from 18/11/2014 to till
date as a Senior Q.A. officer in parenteral division.
The company manufacture different type of hormone’s tablets and injectable products.
Company has approvals of various regulatory bodies like USFDA, MHRA, TGA, ANVISA,
HEALTH CANADA for Tablet section and WHO (local and Geneva) for Injection section.
 I was worked with Nirlife healthcare –A HEALTHCARE DIVISION OF NIRMA, located at
sachana , Ahmedabad as a Q.A. officer in parenteral division in documentation department
and also in IPQA division.
This company manufactures mainly emulsion and amino acids preparations and various
types of TPN products and also general injection.
This company has many approvals like INVIMA, ANVISA, NDA, MOHUKRAIN, and JFDA.
Audit Exposure:-
 WHO (local) and INVIMA, NDA, JFDA.
 Customer audits like Torrent, Bharat-serums.
Area of Interest:-
 Validation
 IPQA
 Documentation department

2. Work profile:-
1) At famy care Ahmedabad (sr.officer-Q.A.) [18/11/2014 to till date]
During my tenture with famy care have diverse roles in Q.A. department in injectable area as
follows:-
 Involvement during execution of various qualification activities in respect to injectable area.
 Preparation and Review of protocols and reports.
 Handling of various instrument during qualification like kaye validator, partical counter etc.
 Apart of it whenever needed, Responsible for line clearance in manufacturing area and
packing area, online verification of documents and process involved inprocess check during
dispensing to dispatch.
 Review of BMR and BPR at each and every stage and at the end of process.
 Investigation of non-conformance.
 Handling of the junior officer and cross check their work during shift.
 Co-ordinate with complies management teams.
 Preparation and Review of SOPs as per schedule.
 Handling and review of Deviation, incident report and CAPA.
2) Nirlife Healthcare- A Division of Nirma (officer-Q.A.) [30/06/2011 to 17/11/2014]
 Ensure and Confirmation of various Formulation like emulsions, amino acids nutrition
supplements(TPNPRODUCTS), liquid, and general parenteral products, special intended
products as per c-GMP or GMP& GLP services to meet specified requirement or quality
purposes before manufacturing handling.
 Issuing the BMR and BPR form SAP and maintain the entry related online process in SAP.
 Corrective Preventive Action carryout during monitoring or evaluating throughout a proper
documentations and ensuring the implementation of correction involved in the process.
 Making the batch manufacturing records as per given tentative formula of F&D.
 Working in parental department as a documentation officer and as a inprocess quality check
officer.
 Making help during manufacturing of the validation batches and its evaluation throughout
processes.
 Checking of the finished packed goods before dispatch it to export or in domestic markets
(pre dispatch inspection).
 Markets complain handling and make a report of it.
Professional skill :
 Knowledge of Microsoft Word / Excel, good communication skills.
 Self motivated and good communication.
 Familiar with SAP system.
 Hardworking and positive attitude nature.
Declaration:-
I here by declare that the above mentioned information is true to best of my knowledge.
DATE:- Hitesh Patel
Place:-
References:-
It will give to you when needed.