I Have 8 Years Exp.As A Sr Quality Assurance Executive With Pharma Mf

CURRILUM VITAE

SANJAY KUMAR SHARMA

Contact No.: 084********

Email: acushk@r.postjobfree.com

OBJECTIVE

TO WORK WITH AN ORGANISATION WHICH HAS CUSTOMER FOCUS APPROACH AND FAITH IN MANAGEMENT SYSTEMS FOR ESTABLISHING IMPROVEMENTS, AND PROVIDES AN ENVIRONMENT FOR ACQUIRING AND PRACTISING INNOVATIVE SKILLS FOR INDIVIDUAL DEVELOPMENT.

ACADEMIC QUALIFICATIONS:

COURSE

COLLEGE

YEAR

DIVISION.

M. SC BIOTECH

C.C.S. UNIVERSITY, MEERUT

2006

FIRST DIVISION

B.SC (Z.C.B)

M.J.P ROHILKHAND UNIV.(BAREILLY)

2003

SECOND DIVISION

INTER

S.D.H. INTER COLLEGE, (U.P BOARD)

2000

SECOND DIVISION

HIGH SCHOOL

S.D.H INTER COLLEGE, (U.P BOARD)

1997

SECOND DIVISION

EXPERIENCE

3 YEARS WORKING EXPOSURE IN SYNMEDIC LABORTORIES (WHO,cGMP CERTIFIED )FARIDABAD FROM 30 MAY 2006 TO 30 JULY 2009 AS A “Q.A EXECUTIVE”

CURRENT EMPLOYER:

IN “RADICURA PHARMACEUTICALS PVT. LTD ” (WHO CERTIFIED) OKHLA PHASE I AS A SR. Q.A EXECUTIVE. FROM 1 AUGUST 2009 UP TO TILL NOW.

JOB RESPONSIBILITY:

DOCUMENTATION WORK

1.MAKING BATCH RECORD (BMR, BPR AND MFR )

2.MAKING SOPS OF ALL DEPARTMENTS.

3.PROVIDE TRAINING OF GMP, SOPs AND MAKING RECORDS OF TRAINING& MULTIPLE CHOICE QUESTIONNAIRES (TRUE OR FALSE) .

4.FACILITY QUALIFICATION RECORDS (MONITORING THE TEMPERATURE AND HUMIDITY IN THE PROCESSING, PACKING AND STORAGE AREAS.)

5.MAKING RECORDS FOR VALIDATION (VALIDATION MASTER PLAN, QUALITY CIRCLE POLICY)

6.SELF INSPECTION AND INTERNAL AUDIT OF ALL DEPARTMENTS.

7.MAKING PROCESS VALIDATION PROTOCOLS, PROCESS VALIDATION REPORTS)

8.UTILITY QUALIFICATION ( AHU QUALIFICATION-DQ,IQ,OQ AND TESTS TO BE PERFORMED BY PQ,- DOP TEST, AIR PARTICLE COUNT, AIR VELOCITY, DIFFERENTIAL PRESSURE MONITORING, AIR QUALITY CONTROL – VIABLE PARTICLES COUNT., TEMPERATURE AND HUMIDITY CONTROL VERIFICATION)

9.WATER SYSTEM QUALIFICATION & ANALYSIS OF DIFFERENT SAMPLING POINT .

10.MAKING PROTOCOLS & REPORTS OF EQUIPMENT QUALIFICATION i.e URS,SAT,DQ, IQ, OQ, PQ.

11.MAKING PROTOCOL AND REPORT OF STABILITY STUDY TEST

12.HANDLING OF MARKET COMPLAINTS AND RECALLS

13.CHANGE CONTROL SYSTEM

14.PRODUCT RISK ASSESSMENT AS PER ISO& cGMP.

15.VENDER APPROVAL QUALIFICATION & SELECTION

16.IN RESOLVING MANUFACTURING AND QUALITY ISSUES .

17.ISSUED,REVIEW AND RETRIEVAL ALL QUALITY DOCUMENTS.

18. ANNUAL PRODUCT REVIEW & TREND ANALYSIS.

CALIBRATION

CALIBRATION OF INSTRUMENT i.e HYGROMETER, BALANCES, D.T APPARATUS,

FRIABILITY APPARATUS

MISCELLANEOUS

COMPLETE KNOWLEDGE OF QUALITY ASSURANCE DOCUMENTS,TABLETS CAPSULES, GRANULATION, COATING AND PACKING SECTION,IN-PROCESS

CHECKS (IPQA WORK)

AUDIT ATTEND:

WHO, cGMP, USFDA, UKRAINE AUDIT & PHILIPPINES AUDIT

PERSONAL INFORMATION:

FATHER’S NAME : MR. MAGNESH KUMAR SHARMA.

NATIONALITY : INDIAN

MARITAL STATUS : MARRIED

LANGUAGES KNOWN : HINDI, ENGLISH

DATE OF BIRTH. : 05/07/1982

POSTAL ADDRESS : GOVIND NAGAR,MORADABAD -244001

DATE:

Signature

( Sanjay kumar Sharma )

Contact this candidate