Pharma Injection-Quality Assurance more than 4 Years of Experience

1. Parikh Pulkit D, M.Pharm (QA)
Address: 39, Ganesh Park, Nr. Shayona city,
R.C Tech. Road, Ghatlodia, Ahmedabad-380061.
Telephone: 9662052330 (M), 8264254348 (M), 07927662509 (R)
E-mail: parikhpulkit09@gmail.com
CAREER GOAL
To work in Quality assurance department in well-established pharmaceutical company, where I can
use my knowledge and skills at there best ability.
SUMMARY OF QULIFICATION
Remarkable experience in Quality Assurance and Handling of various Quality Audits
Proficiency in MS Office, SAP, Internet surfing
Thorough knowledge of GMP regulations, protocols and SOPs
Strong attention to details, Good interpersonal skills, excellent written and oral communication skills
EDUCATION
PROFESSIONAL APPOINTMENTS
4 Years & 1 Month of Total experience in Qaulity Assurance- Injectable
Executive in QA at JAI PHARMA LIMITED- Mylan Lab. Group Company (Previously known as FAMY CARE
LTD.), From Apr - 2015 to Present
Executive in QA at INTAS PHARMACEUTICAL LTD., From Apr - 2014 to Apr-2015
Sr.Officer in QA at INTAS PHARMACEUTICAL LTD., From Jan - 2013 to Apr-2014
Tr. Officer in QA at INTAS PHARMACEUTICAL LTD., From Jan - 2012 to Jan-2013
Tr. Officer in QA at NIRLIFE HEALTHCARE LTD., From July - 2011 to Jan - 2012
Examination/ Degree Board/ University
Year
completed Passing class
M.Pharma
(Quality Assurance)
NIMS University,
JAIPUR
2009-2011 FIRST
B.Pharm RGUHS,
KARNATAKA
2004-2008 FIRST
H.S.C. G.S.H.E.B 2004 FIRST
S.S.C.
G.S.E.B. 2002 DISTINCTION

2. JOB RESPONSIBILITY
Executive-QA at JAI PHARMA LIMITED- Mylan Lab. Group Company
• Ensure cGMP compliance during Different activity in plant
• Responsible for line clearance, In-process checks, sampling in manufacturing and packing
• Identification of GAP in Process & SOP and highlighted to QA manager and Revised it
through raising Change control
• SOP preparation related to IPQA.
• Responsible for handling of Deviation & Market Complaint, Investigate and report it
• Document Review
• BMR & BPR Review
• Participate in Validation Activity going in a Shop-floor
• Submission of BMR & BPR to Doc-QA for its submission to Party
• Communicate with Various other Department for smooth Functioning
Executive-QA at INTAS PHARMACEUTICAL LTD.
• Ensure cGMP compliances & responsible for Line clearance, In-process & surprise checks in
all department store, formulation and packing
• Assure Quality of product maintain during Batch manufacturing, Filling & sealing
• Ensure all operation performed on shop floor as per SOP
• Identify any non-compliance at various stages & ensure that there is no effect on product
quality & treating such things with deviation
• To check material requisition slip
• Withdrawal & Handling of QC sample, sterility sample, retained sample, ADC sample, QP
sample
• Ensure online batch record
• Facing & handling of International audits
• Raise Vendor complaint in-case of any material with OOS observed and fill vendor complaint
form with required information and preliminary investigation and forward complaint to CQA
department
• Investigation of product related market complains
• BMR & BPR Review and its final submission to Doc-QA
• Responsible for Issuance of various production records
• Log books verification of all departments
• Ensure Preventive Maintenance of equipment and its verification against plan
• Perform SAP related QA transaction
• Responsible for non-viable particle count monitoring and preparation of its report
• Responsible for performing AQL
• Actively participate in various validation activities and also in media fill
• Co-ordination with Various other departments for smooth functioning
Tr. Officer-QA at NIRLIFE HEALTHCARE LTD.,
• Stability Analysis of Drug Product for physical and chemical test as per ICH Guideline
• Preparation and Review of Stability Protocol
• Review of Batch Manufacturing and Batch Packing Records
• Provide Stability related documents to Regulatory Department for preparing dossiers and
also assist them in solving queries related to stability.
• Handling of Instruments: HPLC, IR Spectrophotometer, U.V spectrophotometer
AUDIT EXPERIENCES: USFDA, MHRA, ANVISA, TGA, Various Party Audits

3. PERSONAL DETAILS:
 Date of Birth: 15
th
March 1987
 Nationality: Indian
 Laugages known: English, Gujarati and Hindi
 Marital Staus: Married
 Hobbies: Travelling, Listing Music and playing cricket