PUJA GUPTA

Shakti Khand IV, ***, FF, Lane No *, Indirapuram, Ghaziabad, U.P India

Ph: +91-989*******

Email:adddzv@r.postjobfree.com, adddzv@r.postjobfree.com QUALITY CONTROL PROFESSIONAL

QC Professional with 12 yrs of work experience

Working in Unichem Laboratories Ltd (contd...)

Approved by UP State FDA in Microbiological analysis in 2014 Core Competencies Include:

In charge Microbiological Lab.

Rich Exposure of facing various Regulatory Audits

Additional-Stability Management

WORK HISTORY

UNICHEM LABORATORIES LTD,GHAZIABAD JULY 2006-Jun 2018. Worked as Assistant Manager – QC

Joined as Trainee-officer, promoted in 2009 as Executive, in 2012 as Sr. Executive & 2015 as Asstt. Manager Reporting to : Manager-Q.C.

MODHIKE PVT LTD, DELHI MAR 2006-JUNE 2006

Worked as Officer, Documentation

Reporting to : M.D.

CROPHEALTH PVT LTD SEP 2005-FEB-2006

Worked as Trainee

MICRO ASPECT OF WORK EXPERIENCE

Handled a group of 10 including Executive, Sr Officer, Officer & Lab Assistant In charge of all the Microbiological Lab Analysis as briefed below:

Microbiological analysis of raw, Finished, In-process products.

Microbiological media preparation and Growth promotion test of media.

Microbiological analysis of Raw water, Purified water and WFI.

Cultivation and identification of microorganisms.

Viable environment monitoring of sterile as well as non-sterile area.

Maintain/ source lab equipment, inventory of materials.

Trend analysis of water and environment monitoring.

Preparation and implementation of all SOPs.

Training and record maintenance of Microbiological staff.

Equipment Qualification & Requalification

Validation activities

Additional Functional Areas:

Management of Stability Section with respect to sample management & documentation

Review of packaging material documents

PROFESSIONAL COURSE DONE

Did a course in Professional Diploma in Clinical Research (PDCR) from Catalyst Clinical Services Pvt Ltd., Delhi (Aug 2007) PROJECTS DONE /RELATED ACTIVITES

Dissertation on “Quality Control of Recombinant Hepatitis B Vaccine” from National Institute of Biologicals,Noida,UP under Ministry of Health & Family Welfare, India, from March 2005 to June 2005 for partial fulfillment of M.Sc. during 4th semester. Attended a Conference cum workshop in Pune on “Stability Testing Learn by Doing” organized by Prescription Pharma Support on the 3rd

& 4th August’2007. The Speakers were:

1) Dr. Usfeya Muazzam- in charge of Pharmaceutical Quality Div. at B.Farm, Germany 2) Dr. A.V. Prabhu: Member of working committee of I.P. Have worked in the laboratory of my hospital, Santosh Medical College, Ghaziabad during the internship from Sep.’02 to Mar.’03 Have visited the dairy plant of NDRI, Karnal during my M.Sc. & also attended the 45th Annual Conference of Microbiologists held at NDRI, Karnal,Haryana,India in Dec’04.

AUDITS FACED:

Faced audits of USFDA, UK MHRA, MCC, ANVISA, WHO, ISO, Ukraine, Malawi, Dr. Reddy’s, Novartis,Tewa, Niche Generics USA, Waymade U.K., Ranbaxy, GSK, CIMA Labs U.S.A., Uganda, MHO-Ghana, Ivory Coast, Esai Pharma Japan, Rubicon, Matrix, Mylan U.S.A., Tanzania.

EDUCATIONAL JOURNEY

Degree Institute Board/

University

Year of

passing

Subjects % of marks

Matriculation St Joseph’s

Convent High

School, Patna

ICSE Board 1995 English, Hindi,

Science, Maths,

History, Civics &

Geography,

Economics

83% (416 out

of 500)

ISC (10+2) St Joseph’s

Convent High

School, Patna

ICSE Board 1997 English, Physics,

Chemistry,

Biology

73% (290 out

of 400)

B.M.M. (Bachelor of

Medical

Microbiology)

Santosh Medical

College,

Ghaziabad

Chaudhary

Charan Singh

University,

Meerut,UP

2002 MLT, Adv

Serology,

Virology,

Mycology,

Biochem,

Microbio, Human

Pathology, Human

Anatomy, Human

Physiology

68% (1844 out

of 2700)

M.Sc.(Microbiology) Dolphin

Institute of Bio-

Medical &

Natural

Sciences,

Dehradun, U.A.

H.N.B.

Garhwal

University,

UA

2005 Cellular Micro,

RDT, Food Micro,

Microbial

technology, Soil

Micro, Med.

Micro, Mol Bio &

genetics,

Immunology,

bacteriology,

Mycology &

Phycology,

Biochem,

BioStatistics &

Computers

74% (1108 out

of 1500)

Current CTC: Rs. 6.0 Lacs per annum

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