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CURRICULUM VITAE
RAJEEV KUMAR SRIVASTAV
205, Sri Sai Dtta Apartment,Kompally,
RR Dist. Secunderabad-500014
Telangana (India)
E Mail : rajeevsrivastav65@yahoo.co.in
rajeevsrivastav1965@gmail.com
Mobile No: 08498052259,09949364347
Application for the post of: DGM /GM – Quality Control (API/Bulk Drug)
FDA approval -- Approved by Food & drug administration, Bhopal, (MP)
OBJECTIVE:
Seeking a suitable position in quality function of an esteemed organization, where my
Managerial, analytical and Leadership skills can be put for the growth of the organization.
PERSONAL DETAILS:
Father’s name : Sri Birendra Kumar Srivastav
Date of birth : 01-01-1965.
Languages : Hindi & English.
Martial status : Married.
Nationality : Indian.
Passport No : J7849081
EDUCATIONAL QUALIFICATIONS:
1979 – Matric (X) Full time course, Second class, 54% marks.
1981 – I. Sc. (XII) Full time course, Second class, 48% marks.
1985 – B.Sc. (Chemistry Hons) Full time course, Second class, 59% marks.
1989 – M.Sc. (Organic Chemistry) Full time course, Second class, 57% marks.
1992 – LL.B(Taxation & Administration Laws) Full time course, Second class,57% marks
AUDIT FACED:
 Faced "USFDAaudits" in Srini Pharmaceuticals Limited, Nicholas Piramal India Limited
& Different locations of Aurobindo Pharma Limited. (More than 12 USFDA Audits)

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# Current "USFDAaudits" faced directly/indirectly across APIs Units (10 Units) of
Aurobindo Pharma Limited, even one day prior notice and got success:
 Research Centre II:
1. USFDA Investigator: Mrs.Parul Patel (During July 23 rd
to July 26 th
, 2013)
2. USFDA Investigator: Mr.Marvin D Jones (During Dec 3 rd
to Dec 6 th
, 2015)
 Unit V: USFDA Investigator (Mr. Larry K Austin) (During Oct 7 th
to Oct 11 th
, 2013)
 Unit I: USFDA Investigator (Mr.Kham Phommachanh) (During Nov 18 th
to Nov 22
nd
2013)
 Unit VIII: USFDA Investigator (Mr. Michal Goga) (During April 14 th
to April 18 th
,
2014)
 Unit VI: USFDA Investigator (Mrs. Yumi Hiramine) (During Dec 2 nd
to Dec 9 th
,
2014)
 Unit IX: USFDA Investigator (Mr. Bogdrad Zachary) (During March 2 nd
to March 5
th
, 2015)
 Unit XI: USFDA Investigator (Mrs. Bonita Chester) (During April 27 th
to April 30 th
,2015)
 Faced USFDA,TGA,MHRA,ANVISA,KFDA,AGES,COFEPRIS,PMDA, CDSCO,
WHO- GMP, ISO 9001-2008 & 19011-2002,14001 audits in Nicholas Piramal India
Limited & Aurobindo Pharma Limited
 Faced "WHO GMP audit" in Aristo Pharma Limited, Nicholas Piramal India Limited
& Aurobindo Pharma Limited.
 Faced more than 1000 customer audits in Nicholas Primal India Limited, Unimark
Remedies Ltd & Aurobindo Pharma Limited.
TRAINNING / WORKSHOP / APPRECIATION:
 Under one year external training for Bullet Proof Managers.
Trained (during 2 day’s work shop) on Leadership and awarded certificate by
Aurobindo Pharma Ltd..
 Trainined for implementation of LIMS (Going for implementation of LIMS across all
Units of API division)
 Trained (during 2 day’s work shop) on Inter Units Audits by
Aurobindo Pharma Ltd.
 Trained (during 1 days work shop) on "Brain Storming programme" for
Improving plant efficiency and reducing manufacturing cost and awarded
Certificate by Unimark Remedies Ltd.
 Trained (during 1 day work shop) on "Good Titration Practice" and awarded
Certificate by Mettler –Toledo.
 Trained (during 2 day’s work shop) on Practical “Internal auditing of Quality
Management systems" as per ISO9001-2008 and 19011-2002 and awarded
Certificate.
 Trained (during 2 day’s work shop) on how to "Train the Trainer" and awarded
certificate.
 Trained (during 2 day’s work shop) on" HAZOP" and awarded certificate.
 Awarded certificate by Nicholas Piramal India Limited for Higher capacity
Utilization & Productivity.
 Awarded certificate by Nicholas Piramal India Limited for “MISSION USFDA".
TOTAL EXPERIENCE:
About 23 Years only in Quality Control (Chemical / Instrumental / Microbiology)

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 Aurobindo Pharma Limited, Unit I, Borapatla, Hyderabad.
A Public Ltd. company, having more than 2 Billion turnover, Bulk drug/API manufacturer &
EOU. Certified with ISO 9001-2008, 14001, WHO-GMP, ANVISA, TGA, MCC, MHRA, CDSCO,
KFDA, COFEPRIS, PMDA Japan, AGES & USFDA etc.
Deputed as HOD - Quality Control and Microbiology, Since 1 st
March, 2016.
(In APL total about 4 Years only)
. Nature of work: Reporting to.GM - CQC, Leading /working with about 250 no’s Analysts/QC
team & Microbiology team.
 Aurobindo Pharma Limited, Corporate Office, Hyderabad, Telangana (India).
A Public Ltd company, having more than 2 Billion turnover, Bulk drug/API manufacturer &
EOU. Certified with ISO 9001-2008, 14001, WHO-GMP, ANVISA, TGA, MCC,
MHRA,CDSCO,KFDA,COFEPRIS,PDMA Japan, & USFDA etc.
As Senior Manager – CQC, Since 10 th
April, 2013 to continue
Nature of work: Reporting to.GM - CQC, Working with about 40 No’s Lab
Compliance/ GLP team at 10 different Bulk drug/API locations.
Having good knowledge of QMS.
Auditor of Inter Units Audits conducted by CQA.
Responsible for Lab Compliance, Audit & Compliances and to get maintained all Units
(Chemical/Instrumental/Microbiology) Laboratories auditable with respect to Data
Integrity, 21 CFR Part 11, Disaster Management (Back up related activityof
Empower3/Lab solution Server& Stand alone Software’s connected to all analytical
Instruments),Audit Trails review ,OOS,OOT,OOC,Lab Incidents’, Cost
reduction,Centralised decision & procurement of all QC related Infrastructure/ Instruments
/Spares/Chemicals etc.
Harmonization & Implementations of centralized SOPs, STPs, GTPs etc
Location wise establishment of new Laboratories and updation of Infrastructure of
lab.Requitment of Man Power & procurement of Instruments & Equipments as per
Budget for all APIs units against capex approval.
 Aurobindo Pharma Limited, Unit XI, Vishakapatnam, Andhra Pradesh (India).
A Public Ltd company.,having more than 2 Billion turnover, Bulk drug/API
manufacturer & EOU,Certified with ISO 9001-2008, 14001, WHO-GMP, ANVISA, TGA,
MCC, MHRA,CDSCO,KFDA,COFEPRIS,PDMA Japan, & USFDA etc.
As Manager – QC / GLP & Microbiology Since 09 th
July, 2012 to 10 th
April, 2013
. Nature of work: Reporting to DGM - QC, Worked with about 320 QC Eemployees in addition
to Q.C.related supervision for Sampling, analysis of different Raw Materials, In process,
Intermediates, APIs and Packaging materials and dispatch.
Leading a GLP team of about 20 members and Microbiology team about 16 no’s in addition to
Service Engineers.Resposible for any NC and maintaining the Lab auditable with respect to 21
CFR Part 11 related activity, Administrator of all Instruments, Backup activity of
Empowr3 /Class Agent Server, Data Integrity, Audit Trail,Preventive Maintenance &
Calibration of all analytical Instruments, Preparation of SOP, STP, GTP,Protocols etc
IQ,OQ,PQ preparation, Audit & Compliance,OOT,OOS & Lab incident investigation, Change
control & Deviations, PQ of Refrigerator, Calculator,Laboratory, Retentation sample rooms and

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others, Documentation, Document control & review, Working standard management, Analyst
qualification, training activity (introductory, facility, instrumrnts, guidelines & regulatory
related),Analytical method,Cleanning method & Excel sheet Validation, Stability related,
coordination with CRA, CQA, ARD, R&D, Purchase, Instrument service Engineers & Marketing.
Experience to establish 5 No’s new QC Laboratories related to APIs etc.
 Unimark Remedies Ltd. Ahmadabad, Gujarat
A joint venture with HIKMAPharmaceuticals, Europe US/North Africa (MENA).
A Bulk drug/API / Penem Sterile mixture manufacturer, certified by USFDA, EDQM,
WHO, 14001 & OSHAS etc
Worked as HEAD (Manager) – Quality Control and Microbiology, Since 9 th
June,
2011 to 30 th
June, 2012.
Overall responsible for APIs (Penem & Cephalosporins), Sterile APIs mixture
related QC & Microbiology.
Reporting to Sr. VP- Corporate Quality, worked with more than 60 No’s
QC / Microbiology Employees.
API Products: Imipenem, Meropenem, Ertapenem, Cilastatin Sodium, Cefaclor,
Cefprozil Monohydrate, 7ACCA etc
API Sterile Products:Imipenem, Meropenem, Cilastatin Sodium, Sodium
bicarbonate , Sodium carbonate, Sterile mixture of Imipenem & Cilastatin Sodium etc
 Aurobindo Pharma Limited, Unit I, Borapatla, Hyderabad.
A Public Ltd. company, having more than 1 Billion turnover, Bulk drug/API manufacturer &
EOU. Certified with ISO 9001-2008, 14001, WHO-GMP, ANVISA, TGA, MCC,
MHRA,CDSCO,KFDA, COFEPRIS,PMDA Japan, & USFDA etc.
As Dy. Manager – Quality Control & GLP. Since 13 th
May, 2008 to 30 th
May 2011(About 3
Years only)
Nature of work: Reported to AGM - QC,
Worked with about 220 QC employees in addition to QC/Microbiology related supervision
for Sampling, analysis & dispatch of different Raw Materials, In process, Intermediates,
APIs and Packaging materials. Leaded a GLP team of about 20 members in addition to
service Engineers and maintaining the Lab auditable with respect to 21 CFR Part 11
related activity, Administrator of Water Empowr 2 server, Review of Audit Trails/Data
integrity, Disaster Management, Preparation of SOP, STP, GTP, Preventive Maintenance
review and documentation, IQ,OQ,PQ preparation of all Instruments, Audit &
Compliance,OOT,OOS,OOC investigation, Lab incident,Change control & Deviations,
Analytical method adoption from ARD, PQ of Refrigerator, Calculator Control sample rooms
and others,Documentation, Document review, control & retrival, working standard management,
Calibration and preventive maintenance of all QC related Instruments, Analyst qualification,
training activity (introductory, facility, instruments, guidelines & regulatory related),Analytical
method,Cleanning method & Excel sheet Validation, Stability related, Coordination with CRA,
CQA, ARD, R&D, Purchase, Instrument service Engineers & Marketing.
Knowledge to establish new Lab facility etc.
 Nicholas Piramal India Limited, Digwal, Hyderabad. A Bulk drug API Manufacturer, A
Custom Manufacturing Unit ,100% EOU, certified with ISO 9001-2000, WHO, 14001,
MHRA,TGA,ANVISA & USFDA etc.
As Executive - Q.C (Equivalent to Asst. Manager) Since 27 th
January, 2006 to 28 th
April, 2008. (2 Years & 3 months only )
Reporting to VP- Quality

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Nature of work: Lead as Finished product In charge of Q.C.which was Rohedia UK Patent
Anesthetic products (e.g.Sevoflurane, Halothane & Isoflurane) with about 60 no Chemists &
Executives up to world wise dispatch SOP, STP, GTP, IQ, OQ, PQ preparation
documentation, document review, SAP related activity, Working standard management,
Calibration, 21 CFR part 11 Management etc.
From sampling and analysis of Raw materials, Packaging materials and finished products in
addition to World wise dispatch to 80 Countries.
Member of packaging development team of Nicholas Piramal Group.
API Products: Verapamil Hydrochloride, Levobunolol Hydrochloride, Ibuprofen,
Ketoconazole, Diltiazem Hydrochloride, Chloropurine, Promethazine,Cis (+) Hydroxyl lactam,
Halothane, Isoflurine, Sivaflurine,Disflurine & lot of customer products.
 Srini Pharmaceuticals Limited, Hyderabad.(A joint venture with APOTEX INC., Canada.)
A Bulk drug (API) manufacturer,100% exports oriented Unit certified with USFDA, TGA,ISO
9001-2000, WHO, 14001 etc.
As Senior Executive - Q.C. since 25 th
October 2003 to 25 th
January 2006
(About 2 Years & 3 Months only)
Nature of work: In charge of in process & Raw materials with more than 25 no’s Analysts and
reported to Manager-QC. Supervision for sampling, Instruments Calibration, Volumetric
solutions preparation & standardization, Cleaning validation,Water samples Validation &
analysis, SOP, STP, GTP preparation, documentation, document review for FDA audit etc.
 Bajaj Consumer care Limited (Health care division of bajaj group) Hyderabad.
As HEAD (Asst. Manager) - Q.C Since 6 th
December 2000 to 23 rd
Oct 2003(About 2 years &
10 months)
Nature of Work: Quality Control Head: Lead as over all QC In charge with about 10 no’s
Analysts and reporting to Works Manager/GM.
 Cure worth (India) Limited, ( A Unit of Uniworth International group) Chhindwara (M.P) A
Bulk drug (API) manufacturer,
Lead as Shift In Charge/Executive (Second In charge of QC) with about 25 no’s Analysts and
reporting to Asst. Manager - QC. Since 4th
September 1995 to 4 th
December 2000(About 5
Years & 3 months)
Nature of Work:
(As per GMP Norms) Chemical and Instrumental analysis of RM, In process Intermediate
products & Finished goods in addition to all Q.C. activity (e.g. dispatch, documentation, Vender
samples approval, blending decision to dispatch of FP,SOP,STP,GTP preparation, document
review, resolve Customer complain & FDA related works etc.)
Products: Pefloxacin, Norfloxacin, Ciproflaxacin & Cephalexin.
 Aristo Pharmaceuticals Limited, Mandideep, Raisen, M.P. (Pharmaceutical
Formulation) As a Q.C. Jr. Chemist since 16th
June 1993 to 2nd
September 1995.
(2 Year & 3 months)
Nature of Work: (As per W.H.O norms) Analysis of RM, IP, FP and PM, SOP, STP preparation,
Documentations etc, related to Oral formulation (Tablet, Capsule, Syrup, Dry
Syrup, Suspension, Granules and Ointments etc.)
 KNOWLEDGE OF INSTRUMENTS: HPLC, HPTLC, GCHead Space GC, FTIR Spectrometer,
NIR Spectrometer, UV/VIS Spectrometer, Polarimeter,IC,DSC,TOC Analyser, ICPOES, MP
apparatus, KF Apparatus, Moisture meter, Auto potentiometer titrator,pH/TDS/Conductivity Mater,

6. 6
Particle size analyzer / Master Seizer, Sieve Analyzer, Tap density tester, Bursting strength
apparatus, Vernier caliper, Screw gauge, Tablet hardness tester,DT, Friability & Leak test
apparatus etc.
 STRENGTHS:
1. Open to learn new things. Strong work ethics, discipline and self motivated.
2. Committed to strive in achieving the goals.
3. Proficient in delivering timely and productive results in tight deadlines.
4. Good motivator of the self and team under all the circumstances.
5. Maintain good relations with the cross functional teams.
6. Having excellent capability to trained down the lines technically with respect to work in
current scenario.
Salary drawing (CTC) : Total about 15 Lakhs PA
Salary expected : About 20 Lakhs PA
Notice period : 03 Months only (But can be relive earlier as per consent of HOD
& HR or on paying money against early reliving days)
PLACE: Kompally, Secunderabad
DATE: 30/07/2016
(RAJEEV KUMAR SRIVASTAV)
References:
1. My present Boss: Dr. Satyendranath Chakkirala
GM-CQC, Aurobindo Pharma Limited, Hyderabad
Mobile No - 8096555323, E Mail address – satyendranath.chakkirala t@aurobindo.com
2. Ex. Boss: Mr. Navin Kumar Agarwal
AVP-Corporate Quality, Sun Pharma Industries, Vadodara
Mobile No. - 7573010631, E Mail address – navinchery1@yahoo.co.in
3. Ex. Boss: Mr.BVSNS Sastry,
Sr. VP - CQA, Aurobindo Pharma Limited, Hyderabad
Mobile No. - 505505945, E Mail address – sbvsns @yahoo.com
4. Ex Boss Mr. Sunil Deshmukh
Sr. VP – QA (Presently Manufacturing)
Piramal Health Care Limited, Digwal, Hyderabad,
Mobile No - 9849201026, E Mail address – sunil.deshmukh1@pirramal.com
5. First Boss Mr. Vinay Verma
VP – Quality, Sun Pharma Industries, Devas, Indore,
Mobile No - 9755540707,
6. Dr.Hemanth Sharma
Sr. VP – ARD, Research Centre II,Aurobindo Pharma Limited, Hyderabad,
Mobile No - 8455223720, E Mail address – hemant@aurobindo.com