Ankit Kumar Gupta ankit.gpt3@gmail.

com
ANKIT KUMAR GUPTA Objective
Email
[email protected] Intend to build a career with leading pharmaceutical organization
where I can groom myself and at the same time prove an asset to
Permanent Address
the organization. Willing to work as a key player in challenging and
29, Laxmi Bai Marg, Kasrawad,
creative environment.
District-Khargone (M.P.),
Professional Experience
451228
 Company: Base Medico Pvt. Ltd.,
Correspondence Address (Vadodara, Gujarat)
31, Vaikunth Flat, Near Bansider (Project Work)
Duration: Since 16 December 2020 to till date
Flat & Near Randal Mata Designation: Manager – QA
Mandir, Canal Road, Sama,
 Company: Maxheal Laboratories Pvt. Ltd.,
Vadodara (Sachin, Surat, Gujarat)
(Gujarat) (EU-GMP, WHO-GMP, NAFDAC- Nigeria, FDB-Ghana)
Duration: Since March 2015 to December-2020
Mobile No. Designation: Asst. Manager – QA
+918805927712
+919893195139  Company: XL Laboratories Pvt. Ltd.,
(Bhiwadi, Rajasthan)
Personal Data (EU-GMP, PIC’S, PHILIPPINES FDA, VIETNAM, TAZKISTAN)
Duration: Since June 2014 to February 2015
Date of Birth : 29 Jan Designation: Executive – QA
1987
 Company: Titan Laboratories Pvt. Ltd.,
Sex : Male (Mahad - MIDC, Mumbai, Maharashtra)
Nationality : Indian (EU-GMP, TGA, K-FDA, QP-MHRA)
Duration: Since October 2012 to June 2014
Marital Status : Married Designation: Executive – QA
Languages Known: English,
 Company: Kopran Pharmaceuticals
Hindi (Savorli, Mumbai, Maharashtra)
Assets: (MHRA, EU-GMP, MCC-South Africa, TGA-Australia)
Duration: Since February 2012 to September 2012
1. Effective Communication Designation: Executive - QA
skill and leadership qualities.
 Company: Mission Vivacare Limited
2. Highly motivated to work as (SEZ Pithampur, Madhya Pradesh)
a team. (WHO-Geneva)
Duration: Since September 2010 to January 2012
Designation: Officer – QA

Professional Responsibilities
 Handling green field project work like review of layouts, RDS, AHU
Schedule and discussion with manufacture and consultant as per
requirement.
 Handling and preparation of projected related documents like facility
qualification, equipment / instrument qualification, utility related
qualification, departmental SOP and Quality Management System etc.
 To conduct the FAT of Production, QC, Micro, Engineering Related
equipment and instrument.
 Handling and preparation of Audit and license related documents.

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Ankit Kumar Gupta [email protected]
 Handling of Internal and External Audits.
 Handling, review and approval of change control procedure.
 Handling, review and approval of deviation handling procedure.
 Handling, review and approval of document ratification proposal.
 Handling, review and approval of document control procedure.
 Handling, review and approval of self-inspection record.
 Handling, review and approval of training programmers.
 Handling, review and approval of market Complaints.
 Handling, review and approval of product recall procedure.
 Handling, review and approval of Corrective and Preventive Action
(CAPA).
 Handling, review and approval of Out of Specification (OOS).
 Handling, review and approval of New Product Introduction Procedure.
 Handling, review and approval of Annual Product Quality Review
(APQR).
 Handling, review and approval of Quality risk assessment &
management.
 Handling, review and approval of Quality Meeting.
 Handling, review and approval of vendor Qualification data.
 To conduct the vendor audit and external lab audit as per planner.
 Approval and technical agreement with approved external service
provider.
 Handling, review and approval of stability protocol for stabilities studies.
 Handling, review and approval of process validation & hold time study
protocols & its reports.
 Handling, review and approval of cleaning validation & equipment hold
time study protocols & its reports.
 Handling, review and approval of area qualification and preparation of its
DQ, IQ, OQ & PQ protocol & reports.
 Handling, review and approval of equipment qualification like DQ, IQ,
OQ & PQ protocol & reports.
 Handling, review and approval of compressed air validation protocol &
report.
 Handling, review and approval of water system validation protocol &
report.
 Handling, review and approval of Area and equipment temperature
mapping protocols and reports.
 Handling, review and approval of calibration record and its trends.
 Handling, review and approval water trend results.
 Handling, review and approval of SMF, VMP, Training manual & Quality
manual.
 Handling, review and approval of Batch records and Batch release.
 Handling of IPQA and production related activity.

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Ankit Kumar Gupta [email protected]
 Review and approval of all documentation, instructions, specifications
and standards which may impact product quality (e.g. Policies,
Manuals, SOP’s, Batch records, layouts, Organogram, Technical
agreement, test methods, Trends, Protocols & Reports, etc.).
 To ensure that all necessary controls on intermediate products and
any other in-process controls and validations are carried out.
 Establishing a system to release or reject in-process & finished
products.
 Handling & coordination with our team and inter department like
Production, warehouse, QC, Micro, Engineering and HR department on
day-by-day activity.
 To handle the recruitment of employee as per direction by MD.

Education
 Master of Pharmacy in Pharmaceutices (73.54 %) 2008-2010, Rajiv Gandhi Proudyogiki
Vishwavidyalaya, Bhopal (M.P.), India.
 Bachelor of Pharmacy (71.88 %) 2004-2008, Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal,
(M.P.), India.
 Higher Secondary School Certificate Exam (62.44 %) 2003 in M.P. Board, Bhopal (M.P.).
 High School Certificate Exam (77.2 %) 2001, in M.P. Board, Bhopal (M.P.)

Audit Faced
 Indian-WHO-FDA
 WHO – GENEVA
 TGA – AUSTRALIA
 EU-GMP (Malta, Hungary & Greece)
 QP - MHRA
 MCC - South Africa
 K-FDA (Korea)
 PHILIPPINES FDA
 NAFDAC - Nigeria
 FDB - Ghana
 Some Customer Audit like Mylan- Nashik, Aspen-South Africa, Sanofi, Aurobindo, RIA etc.

Project/Training Undertaken

 As my B.Pharm project, I worked in “Study a novel Alpha-amylase enzyme: Production & Partial
Purification” under kind guidance of Mr. Rakesh Punasiya.
 As my M.Pharm project, I worked on ““Formulation and in-vitro evaluation of Self emulsifying drug
delivery system of antihypertensive drug valsartan” under kind guidance of Dr. S.C. Mahajan.

Achievements
 Conferences
o Attended 61st, Indian Pharmaceutical Congress, Ahmadabad in Dec-2009
o Indian Pharmaceutical Association, Indore in Feb-2010
o National seminar, G.R.Y. institute of Pharmacy, Borawan, Khargone
 Extra Qualification
o Diploma in Drug Regulatory Affairs (D.D.R.A.)
o Diploma in Intellectuals Copy Rights (Wipo DL 101)
 Paper Publication
o International Journal of Pharmacy & Life Sciences (IJPLS): Research Article: Preparation
and Evaluations of Self Emulsifying Drug Delivery System of valsartan.

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Ankit Kumar Gupta [email protected]
Computer Literacy
 Operating System: Windows: 98, 2003, 2007, 2011, 2015,2020
 Scientific data retrieval from various Internet portals like Google scholar, Science Direct, Pubmed,
etc.
 Working Knowledge of following Softwares: Microsoft Office package (MS word, Excel, Power
point)
Industrial Training and Industrial Tour
 Industrial training in Parental Drug Pharmaceutical Ltd. (P.D.P.L.), Indore.
 Blue Cross Laboratories Ltd, GOA
 Centaur Pharmaceuticals Pvt. Ltd, GOA

Declaration
I hereby declare that all the details furnished above are true to the best of my knowledge.

Place: Vadodara (Ankit Kumar Gupta)

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