Narender Adepu is a highly qualified and experienced Quality professional seeking a manager position in Quality. He has over 14 years of experience in Quality for API and pharmaceutical manufacturing. He holds an M.Sc. in Chemistry and has worked for several major pharmaceutical companies in various Quality roles, managing laboratories and leading audits. His technical skills include proficiency with GMP/GLP systems and analytical instrumentation.

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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