1. CURRICULUM VITAE
G.CH. RAMA NAIDU, Email: ramanaiduc@yahoo.co.in
CELL: +91-9553992262 ramanaidu.gorripati@hospira.com
OBJECTIVE:
To associate myself with a reputed pharma company where I can explore my knowledge and
ability to be a part of the team that works dynamically towards the growth of the organization.
I am eager to prove that my intelligence, competence, maturity and enthusiasm will be a
positive contribution to your organization. I always welcome the challenge to perform
multiple activities.
AREAS OF EXPERTISE:
Stability, In-process & Finished Product, Raw Material , Analytical Equipment's Qualifications
& Calibrations, Analytical Method Validations and Method Verification's, Method Transfers,
Investigations, Review and Compliance.
EXPERIENCE: 8 YEARS 5 MONTHS
Name of the Company Designation Duration
Pfizer, Visakhapatnam Assistant Manger December-2012 to till date
Apotex Research Private Ltd,
Bangalore
Analyst Aug-2012 to Nov-2012
Aurobindo Research Centre,
Hyderabad
Research Associate-IV April-2011 to July-2012
Hospira Health Care India Pvt Ltd,
Chennai
Executive May-2007 to March-2011
KEY RESPONSIBILITIES:
 Planning for the Chemical and Instrumental analysis of Raw materials, In-process &
Finished product and Stability samples
 Analytical Method validations/ Method Transfers/Method Verifications
 Review of Analytical documents followed as per cGMP, 21 CFR and Quality policy’s
 Maintain real time documentation and Laboratory safety around the clock
 Qualification and Calibration of instruments like HPLC, GC, UV, IR etc
 Handling of Exceptions, Laboratory Investigations, CAPA’s and Change controls
 Preparation and review of SOP’s, STP’s, Work sheets ,Certificate of Analysis and Method
Validation & Verification Protocols
 Preparation of Audit readiness
 Responsible for procurement of Reference standards, Chemicals, HPLC and GC Columns
 Responsible to provide training to new chemists on activities

2.  To participates in Trouble shooting of Instruments
 Responsible to check the Audit trials, creation of Instrument methods and Processing
methods and Monitoring of GLP Practices in the Laboratory
HAVING EXPERIENCE ON:
 Preparation of Analytical Method Validation, Method Verifications protocols and Summary
reports
 Expertise on Analytical Method Validations of Assay’s, Related substances by HPLC and
Residual Solvents by GC as per ICH guidelines
 Analytical Method Verifications and Feasibility studies for Compendial methods
 Daily planning and tracking of the IP/FP and Stability samples for analysis
 Analysis of Related substances and Assay by HPLC, Residual solvents by GC as per
STP’s
 Generation of Working standards and Maintain usage records of Primary Standards,
Working Standards and Reference Standards
 Stability studies are performed on Drug products and Drug substances at appropriate
interval as per Stability study protocol
 Preparation of Stability study protocols and Stability summary reports
 Involved in analysis of samples related to pre Exhibit and Exhibit batches intended for
submission to regulatory bodies of the USFDA, Europe (EQDM), Japan and Australia
 Involved in analysis of Process Validation batches
 Involved in analysis of Cleaning validation batches
 Calibration of Instruments as per Master schedule
 R&D support analysis
 Preparation and Standardization of Volumetric solutions
 Good Exposure on all dosage forms
 Laboratory Investigations and incidents through “Track wise”
INSTRUMENTS HANDLED:
 Waters HPLC, UPLC with Empower software.
 Agilent HPLC (1100 series &1200 series) with Chemstation and Empower Software.
 Shimadzu HPLC(2010) with LC solutions software
 GC-Agilent 6890 &7890 with HSS and Perkin Elmer, Clarus-680
 Per kin Elmer FT-IR with Spectrum Software.
 UV-Visible Spectrophotometer(Per kin Elmer & Shimadzu)
 Dissolution Apparatus-Lab India, Electro Lab, Distek (Online UV) and Sotax (USP IV
Apparatus)
 Auto titrator, KF Titrator, Polarimeter, pH, TOC
 Horiba Globule Size Analyzer LA-950, Automatic Particle Sizing Systems-NICOMP

3. AUDITS FACED:
 US FDA, M.H.R.A (UK). W.H.O, T.G.A
EDUCATIONAL QUALIFICATION:
M.Sc. ( Chemistry) from Andhra University
 B.Sc. (M.P.C.) from Andhra University
 Intermediate(M.P.C) from Board of Intermediate Education
 S.S.C from School of Secondary Education
PERSONAL PROFILE
Name : G.CH RAMA NAIDU
Date of Birth : 01-07-1979
Gender : Male
Marital Status : Married.
Nationality : Indian
Linguistic Proficiency : English, Telugu & Hindi
PASSPORT DETAILS
Passport number : L6471430
Date of issue : 07-01-2014
Date of Expiry : 06-01-2024
Place of issue : Visakhapatnam
DECLARATION
There by solemnly declare that all that statements are true and correct to the best of my
knowledge and belief. Nothing has been concealed.
PLACE: Vizag, India
DATE : (G.CH RAMA NAIDU)