1. CURRICULAM VITAE
NARENDER ADEPU
H.No 6-11-79,
AMBEDKAR NAGAR,
JAGGAIAHPET,
BEHIND YOGI RAM HOSPITAL, MOBILE NO: +91 9000198881
KRISHNA DIST.,(A.P) E- mail: mailnadepu@gmail.com
CAREER OBJECTIVE:
A highly motivated, committed and qualified looking for a challenging and responsible
position in Quality with exposure over 14 year to excel in the field of pharmaceuticals.
SUMMARY OF QUALIFICATIONS:
ACADEMIC QUALIFICATIONS:
 M.Sc., (Chemistry) from Kuvempu University, Bangalore.
 Bachelor of Science Degree from Kakatity University.
TECHNICAL SKILLS:
TECHNICAL SKILL FAMILIARITY
MS-Office Familiar
Typing 40 words per minute
Empower 3.0 Software Expert
Lab Solution Software Expert
Tiamo 1.2 & 2.1 Expert
Newtronics ICDAS 1.4 Expert
Thermolab Stability 5.7T Expert
MACK DAAS Familiar
Internet Familiar
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2. PROFESSIONAL EXPERIENCE:
 Over Fourteen Years of experience in API, Sterile API Pharmaceutical, Oral and
injectable Formulations.
 Presently left from the RA Chem Pharma Limited,API Division as “Manger-QC” since
26,May-2016.
PREVIOUSLY WORKED WITH
NAME OF THE ORAGANIZATION DISGNATION PERIOD
Aurobindo Pharma Limited, Hyderabad
Unit-6(Formulations) and
Unit-8( API manufacturing)
Asst.Manger-QC Mar 2008 to Dec 2013
Ranbaxy Laboratories Limited (DEWAS Unit)
Near Indore (Oral and injectable Formulations)
Sr.Officer- Stability Jan 2006 to Feb 2008
Mylan Laboratories Limited (Unit-1)
Hyderabad(formerly know as Matrix
Laboratories) (API manufacturing)
Sr.Chemist-QC May 2004 to Jan 2006
Aurobindo Pharma Limited (Unit-5)
Hyderabad (API and Sterile API manufacturing)
Assistant-QC Mar 2002 to Apr 2004
JOB RESPONSIBILITIES:
 Planning and monitoring the overall functioning of the analytical laboratory as per ICH,
USFDA and EU guidelines.
 Maintaining and controlling documents as per ICH, USFDA, and EU standards.
 Daily activities reporting to Asst.General Manager-QC.
 Ensuring good housekeeping in laboratory.
 Train the analysts on instruments operation and good documentation skills.
 Responsible to participate in internal audits as per the schedule.
 Handling of Customer Complaints, OOS Investigations and return goods.
 Aware the microbial analysis of Purified water (TMC, TYMC and Pathogens)
 Successfully completed purified water system validation.
 Aware on analytical method validations as per ICH Q2R1.
 Responsible for trend chart preparation of finished product analytical results.
 Responsible for Review of Audit trails in various applicable software as the schedule.
 Handling of Laboratory incidents with corrective and preventive actions and
preparation of Incident summary reports with trending on monthly basis.
 Review of the Schedules of Master Calibrations, AMC, PM and stability.
 Monitoring the retention samples of API’s, intermediates and key starting materials as
per pre-defined procedure.
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3.  Handling of Out of trend (OOT) with corrective and preventive actions and preparation
of summary reports with trending on monthly basis.
 Monitoring the working standards qualification as per Pharmacopoeia reference
Standards.
 Responsible for Monthly Report preparation on overall activities to submit
management.
 Co-ordinate with various departments like QA, MANUFACTURING, PPIC, RA and
R&D to complete the work.
 Responsible for compilation and Trend chart preparation of Stability data.
 Ensuring the calibration of instruments as per schedule.
 Responsible for Method Transfer of new Molecule to the lab.
 Indenting of chemicals /columns /glassware/spares/other operational supplies.
 Responsible for review of daily and monthly backup activity of all analytical
instruments, chambers and HPLC server.
 Review and approve protocols and reports such as method validation, method transfer,
process validation and stability.
 Review and approve Certificate of Analysis, Certificate of Test and stability studies.
 Serve as QC lead on analytical projects teams and product operational teams.
 Collaborate with regulatory to support filling/amendments.
 Establish and review training curricular for the QC department to develop a
comprehensive QC laboratory training plan.
 Designing and conducting Stability studies as per ICH and WHO Guidelines.
 Review and approve Quality Control Laboratory records including environmental
monitoring, deviations, corrections, change controls, OOS and lab investigations.
 Manage Quality Control budget and responsible for implementing cost savings within
the department.
 Perform other duties as may be required or necessary.
ADDITIONAL RESPONSIBILITY AS ADMINISTRATOR:
 Responsible for New monthly project creation and new logins and passwords
creation/deletion/activation/deactivation in Empower/Lab solutions/Tiamo and other
softwares.
 Responsible for Back up of Server data.
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4. KNOWLEDGE ON WORK:
 A detail-oriented, sincere and hardworking individual with a Master of Science and
Over Fourteen years of GLP/GMP work experience.
 Working experience on 21 CFR part 11 compliance.
 Expert in Audit trails review in Empower, Lab solutions, Tiamo and other
software’s.
 Experience in theoretical and practical knowledge in calibration, preventive
maintenance, troubleshooting and problem solving of critical equipment like HPLC,
GC, Auto Titrator, DR and UV-Spectrophotometer etc.
 Technical skills leading to accurate and consistent laboratory results, calculations,
report writing and presentation.
 Ability to learn new techniques quickly; work independently, commitment to
quality, excellent interpersonal and communication skills.
 Very open to any idea to work on and very determined to complete the job in time.
 Proficient in literature survey and interpretation of the data.
 Excellent self-motivated team player with good communication and interpersonal
skills coupled with strong analytical and problem solving ability.
 Working experience on ERP through online network.
PRESENT ORGANOGRAM
Head Corporate Quality
Asst.General Manager(Head –QC)
ManagerMy Self as Manager
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Asst.Manager
(Mylan CMU & Doc)
Sr.Executive
(Stability)
Sr.Executive
(GLP)
Executive
(Dispatches)
Executive(4 No’s)
(Shift in-charges)
2 Chemists
2 DEO
2 Chemists 1 Chemist 30 Chemists4 Chemists

5. AUDITS FACED:
 Faced audits of various regulatory authorities of following.
USFDA : 3 times (2 Times directly faced)
MHRA : 1time (1 Times directly faced)
ANVISA BRAZIL : 2times (2 Times directly faced)
KFDA : 2times (2 Times directly faced)
MEXICO COFEPRIS : 2times (2 Times directly faced)
MCC, TGA : 1time ( Supported as Member)
Major Customer Audits like
Pfizer, GSK, PAR, ABBOTT,
Mylan and Foreign customers
: More than 50 directly faced
Domestic Customers : More than 100 directly faced
My Strength: Good Communication and Interpersonal Skills, Honest and dedicate.
KNOWLEDGE ON INSTRUMENTS:-
INSTRUMENT MAKE
HPLC
Waters Alliance and Agilent 1100 with Empower -3 Software.
Shimadzu LC-2010C HT with Lab Solution Software.
GC
Agilent with Empower -3 and Chemistation/Chemistore Software,
Shimadzu LC-2010 plus & LC-2014 with Lab Solution.
Dissolution DISTEK, Electro lab
UV Spectrophotometer Shimazdu UV 1800 with UV probe and Perkin Elmer
FTIR
Perkin Elmer with Spectrum One Software
& Shimazdu 8400S with IR solutions
PSD analyzer Malvern 3000
Disintegration Tester ED-2 by Electro lab
Friabilator EF-2 by Electro lab
Polarimeter Jasco and AUTO POL-IV RUDULPH REASEACH.
KF Titrator Metrohm 890 with Tiamo Software, Polmon
Auto Titrator Metrohm 794 with Tiamo Software
pH meter Lab India, Metler and Polmon LS132
ACHIEVEMENTS:
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6.  Most of MS-Excel Calculation Sheet for (Assay/RS/DR) prepared and validated at
Aurobindo Pharma Limited Unit-6.
 Actively participated in TGA and MHRA audits and received excellent document
presentation appreciation at Ranbaxy laboratories Limited (DEWAS,M.P).
 Independently operated separate Stability Cell from for around 4 years in Aurobindo
Unit-8.
 Successfully lead the team without any major observation during major Audits like
USFDA,KFDA,ANVISA,WHO,MEXICO,COFEPRIS and major customers like
Pfizer,GSK,SUN etc.,
 Audited other Aurobindo Pharma units as per scheduled inter unit audits and
supported them during the major audits.
 6 API’s packing profile changed (adopted) successfully for stability consistency in
Aurobindo Unit-8.
 Around 35 API’s profile Trend charts prepared successfully applied for retest date
Extension and got approval from regulatory agencies in Aurobindo Unit-8.
 Evaluated and discontinued unwanted Stability study sample and saved analytical
cost and received appreciation from management in Aurobindo Unit-8.
TRAINING ASSETS:
 UPLC AND WATER COLUMNS CONDUCTED BY M/S WATERS (I) Pvt.,
Ltd.at Indore.
 ATTENDED INTERNAL TRAINING PROGRAMS SUCH AS SAFETY
CLASSES, GMP, GLP and HPLC TROUBLE SHOOTING AND TECHNIQUES.
 HPLC TROUBLE SHOOTING “CONDUCTED BY M/S.CHROMLINE
EQUIPMENTS (I) PRIVATE LIMITED.
 “EMERGING TRENDS IN CHROMATOGRAPHY COLUMNS” CONDUCTED
BY M/S. CHROMATOPAK ANALYTICAL INSTRUMENTS (INDIA)
PRIVATE LIMITED.
GOAL:
 To become a “Quality Auditor”.
PERSONAL DETAILS
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7. Father’s name : A.Jagannadham (Late)
Date of Birth : 18-10-1976
Marital status : Married
Languages Know : Telugu, English, Hindi
(Able to speak, write, read all three Languages)
Hobbies : Reading, Net browsing...
Permanent Address : Flat No.:G2,
Chaitanya Residency
Shubodaya Colony, KPHB Colony,
Hyderabad-500072,
Telangana State, India.
Contact no. : +91 90000198881
Present Address : H.No : 6-11-79,
Abethkar Nagar,
Behind Yogi Ram Hospital,
Kodad Road,
Jaggaiahpet-521175
Krishna Dist.,(A.P),India
Place:
Date: (A.Narender)
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