Quality assurance- Validation Qualification department.

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 UniversityOf
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 5 years in Pharmaceutical industries in Parenteral division.
 During my job, I had faced many successful audits like MHRA, INVIMA and NDA and ANVISA.
 Presently I am working in INTAS Pharmaceutical ltd at Matoda plant in Parenteral division,
from 07/03/2016 to till date as posted Sr.officer in quality assurance division.
 Company has approvals of various regulatory bodies like USFDA, MHRA, TGA, ANVISA, and
HEALTH CANADA.
 I was worked with Sun Pharmaceutical Ltd, Halol at vaddodara as a officer-1 in validation
department. I was worked in parenteral division process validation and master BMR review
department.
 I was worked with FAMYCARE LTD, Ahmadabad at Pharmez as a senior officer in validation
department. I was worked in parenteral division validation and qualification department.
 I was worked with Nirlife healthcare –A HEALTHCARE DIVISION OF NIRMA, located at
sachana , Ahmadabad as a Q.A. officer in parenteral division in documentation department
and validation department.
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, MOH-UKRAIN, and JFDA.
Audit Exposure:-
 WHO (local) and INVIMA, NDA, JFDA.
 Customer audits like Torrent, Bharat-serums.
Area of Interest :-
 Validation and qualification.
 Documentation department
 Market complaint department

2. Work profile:-
1) At Intas Pharmaceutical Ltd. [07/03/2016 to till date]
During this period with Intas pharmaceuticals have diverse roles in Q.A. department in
validation department mainly in Injectable area as follows:-
 Involvement in Qualification of the Microsphere skid.
 Review of Qualification document and report.
 Review of the party document for the new equipment.
 Involvement in media fills activities during media fill.
 Reviews of media fill BMR.
 Review of design qualification document as per URS and performed FAT.
 Involvement during various qualifications like HVAC, Autoclave, utility, De-pyrogention
tunnel, CIP SIP unit and various manufacturing and Holding tank.
 Review of qualification data ongoing in plant.
 Review of SOPs.
2) At Sun Pharmaceutical, Halol (officer-1 Q.A.) [10/08/2015 to 07/03/2016]
During this period with Sun pharmaceuticals have diverse roles in Q.A. department in
injectable area as follows:-
 Involvement in manufacturing of the process Validation batches and its evaluation
throughout processes.
 Making and review of process validation and cleaning validation protocol and report.
 Involvement in Cleaning Validation.
 Involvement in media fills activities during media fill.
 Reviews of media fill BMR.
 Review of master BMR as per master formula given by F&D department.
 Review of qualification data ongoing in plant.
 Review of SOPs.
3) At famy care Ahmedabad (sr.officer-Q.A.) [18/11/2014 to 10/08/2015]
 Involvement during various qualifications like HVAC, Autoclave, utility, De-pyrogention
tunnel, CIP SIP unit and various manufacturing and Holding tank.
 Review of protocols and reports.
 Doing of various qualification activities in respect to Injectable area.
 Handling of the junior officer and cross check their work.
 Co-ordinate with complies management teams.
 Preparation and Review of SOPs as per schedule.
4) Nirlife Healthcare- A Division of Nirma (officer-Q.A.) [30/06/2011 to 17/11/2014]
 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.
 Markets complain handling and make a report of it.
 Involvement during various qualifications like HVAC, Autoclave, utility, De-pyrogention
tunnel & process Validation batches.

3. 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:-
Place:- Hitesh Patel
References:-
It will give to you when needed.