Published on: Mar 3, 2016
Transcripts - NAREN_CV
BEHIND YOGI RAM HOSPITAL, MOBILE NO: +91 9000198881
KRISHNA DIST.,(A.P) E- mail: email@example.com
To obtain a Quality position in the field of Pharmaceutical industry where my academic
credentials, skills and expertise can be utilized to the growth and success of your organization..
Intended position: Suitable position in your Esteemed Organization.
SUMMARY OF QUALIFICATIONS:
M.Sc.,(Chemistry) from Kuvempu University, Bangalore.
Bachelor of Science Degree from Kakatity University.
TECHNICAL SKILL FAMILIARITY
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
Over Fourteen Years of experience in Formulations, API and Sterile Pharmaceutical.
Presently working as “Manger-QC “in RA Chem Pharma Limited,API Division since
PREVIOUSLY WORKED WITH
NAME OF THE ORAGANIZATION DISGNATION PERIOD
Aurobindo Pharma Limited (Unit-8)
Hyderabad (API manufacturing)
Mar 2010 to Dec-2013
Aurobindo Pharma Limited (Unit-6)
Hyderabad (Sterile and oral Formulations)
Feb-2008 to Mar-2010
Ranbaxy Laboratories Limited (DEWAS Unit)
Near Indore (Oral Formulations)
Sr.Officer-Stability Jan-2006 to Feb-2008
Mylan Laboratories Limited (Unit-1)
Hyderabad(formely know as Matrix
Laboratories) (API manufacturing)
May-2004 to Dec-
Aurobindo Pharma Limited (Unit-5)
Hyderabad (API manufacturing)
Assistant-QC Mar-2002 to Apr-2004
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.
Participated 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
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
Perform other duties as may be required or necessary
ADDITIONALRESPONSIBILITY AS ADMINISTRATOR:
Responsible for New monthly project creation and new logins and passwords
creation/deletion/activation/deactivation in Empower/Lab solutions/Tiamo and other
Responsible for Back up of Server data.
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 softwares.
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.
Head Corporate Quality
Asst.General Manager(Head –QC)
My Self another Manager
Data Entry operators (2No.s)
Faced audits of various regulatory authorities of following.
USFDA: 2 times
MHRA : 1 time
ANVISA BRAZIL: 2 Times
KFDA : 2 Time
MEXICO COFEPRIS: 2 Times
MCC, TGA : 1 time
And may more major Customer like Pfizer, GSK, PAR, ABBOTT and Mylan etc.
My Strength: Good Communication and Interpersonal Skills, Hardworking and responsible.
KNOWLEDGE ON INSTRUMENTS:-
Waters Alliance and Agilent 1100 with Empower -3 Software.
Shimadzu LC-2010C HT with Lab Solution
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
Perkin Elmer with Spectrum One Software
& Shimazdu 1800S with IR solutions
PSD analyzer Malvern 3000
Disintegration Tester ED-2 by Electro lab
Friabilator EF-2 by Electro lab
Polarimeter Jasco 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
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 operating separate Stability Cell from last 3 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
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
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.
UPLC AND WATER COLUMNS CONDUCTED BY M/S WATERS (I) Pvt., Ltd.at
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
AVP-CQA, Mylan Laboratories Limited.
Head-Corporate Quality Control Hetero drugs Limited.
To become a “Quality Auditor”.
Father’s name : A.Jagannadham (Late)
Date of Birth : 18-10-1976
Marital status : Married
Languages Know : Telugu, Hindi, English
(Able to speak, write, read all three Languages)
Hobbies : Reading, Net browsing...
Permanent Address : Flat No.:G2,
Shubodaya Colony, KPHB Colony,
Telangana State, India.
Contact no. : +91 90000198881
Present Address : H.No : 6-11-79,
Behind Yogi Ram Hospital,