1. CURRICULUMVITAE
G. RAMANJANEYULU
C/o S.K.Haroom,
H.No:17-59/21, Plot No: 91,
Ramnagar colony, Alwal
Secendrabad-500010. Mobile No: +91 8886534747,+91 8886534848
India Email: ramanjaneyulu10_g@yahoo.co.in.
Objective:
To associate myself with an organization where there is an opportunity to carve up,
contribute, perk up my knowledge and work as a team toward the success of the
organization.
Experience Summary : 11 years 3months of Experience in Pharmaceutical analysis
and documentation (Formulation).
AUDITS FACED
US FDA, MHRA, TGA, WHO, CANADA and POLAND.
EDUCATIONAL QUALIFICATIONS:
1 M.Sc.,(Analytical Chemistry) from SRTM University, Nanded (2003-2005)
2 B.Sc., (Maths, Physics and Chemistry) NagarjunaUniversity.
Current Employer: Novartis Health Care LTD,
R&D Hyderabad.
Duration: From Dec-2012 To Till date.
Previous Employer: Micro Labs Ltd,
Quality Control (Corporate Analytical Department).
Unit I ,II& III, Formulation Units Hosur,
Duration: From April 2011 To Dec-2012.
Previous Employer: Aurobindo Pharma Limited,
(Formulation Unit-III) Stability Department,
Hyderabad.
Duration: From July 2007 to April 2011.
Previous Employer: NATCO Pharma Limited,
(Formulation Unit -1V) Hyderabad
Chemist in Quality Control Department
(June2005 to July 2007)
2. Present Experience:
Working as a Senior Scientist in ARD India in Novartis Health Care LTD, Hyderabad.
Executed the end to end responsibility of various project with Registration,
clinical and technical stability projects.
Meet quality, quantity and timelines in all assigned projects of Method Validation
and Clinical stability
Various kind of Documentation done in TEDI data base (Technical
documentation information system) for example preparation of SOP’s,
Analytical methods, specifications, Stability reports (DSR), validation protocols
and reports, validation summaries etc.
Review and approval of Clinical Stability analysis Reports for its correctness,
completeness and trending of stability data.
Review and approval of release, retest (Clinical) batches for various projects
Involving in the OOS/OOT /Deviation investigation and its documentation and
reporting with respect to cGMP norms.
Responsible for frequent Auditing of Analytical Department as per self-
inspection plan and also to ensure compliance against previous audit
observations.
Understanding of Laboratory information management system, to perform the
various operations.
Expert in OOS/OOE/OOT data management system with AQWA(Analytical
quality work flow)-application
Review and approval of Qualification document of various analytical instruments
and equipment’s .
3. Previous Experience:
Worked with Micro labs LTD Unit-I,II&III Hosur Quality control (Analytical Review
Team) as a Reviewer.
Review of all the Analytical reports of Raw material, finished product for its
correctness &compliance to the system before they are being released for use and
distribution.
Review of Stability analysis Reports for its correctness and trend analysis.
Reviewing and approval the calibration Reports of all Analytical instruments.
Reviewing of master Analytical work records for its correctness.
Reviewing and updation the Raw material and Finished Product STP’s, inline
with Pharmacopieal monograph.
Updation of General testing procedures in line with Pharmacopieal general
chapters.
As part of AQA, Participating in the OOS/OOT/Deviation investigation and its
proper documentation and reporting.
Actively involved in Internal &Regulatory Audits.
Previous Experience:
Worked as a Executive, Quality Control, Stability studies at AUROBINDO PHARMA
LTD, Unit–III, Formulation division, Hyderabad. (July2007 to April 2011).
Job responsibilities:
Analysis of Stability Samples.
Calibration of Analytical Instruments.
Analysis of Stability samples for commercialized & exhibit batches for various
regulatory markets, as per ICH Guidelines
Investigation of OOS/ OOT and Incidents.
Monitoring stability Chambers
Preparation & review of Worksheets.
Review and approval of Analytical reports.
Compilation & Submission of Stability data.
Reporting and Review of data in Laboratory Information
Management System (LIMS).
4. Previous Experience:
Worked in NATCO PHARMA LTD, Hyderabad (Formulation unit 1V-USFDA
Approved Plant) as a Chemist in Quality Control Department (June2005toJuly 2007)
Job responsibilities:
Finished Product and stability samples Analysis
Maintaining documents as per cGMP requirement.
Troubleshooting and maintenance of various analytical instruments
Hands on experience in the operation and calibration of analytical instruments.
Reviewing stability studies protocols and records.
Indenting of chemicals / columns / glassware / spares / other operational supplies.
Handling of various instruments like i.e., HPLC, UV Spectro photometer, IR
Apparatus Autotitrator. KF apparatus, Friability apparatus, Dissolution,
Disintegration, etc.
Personal profile:
Name : G. Ramanjaneyulu
Koniki post, Inkollu mandal
Prakasam District ,Andhra Pradesh
India, PIN :523167
Date of Birth : 10th June 1980
Languages Known : English, Hindi and Telugu.
Declaration:
I hereby declare that the above-furnished information is correct as per the best of
my knowledge and I bear the responsibility for the correctness of those above-mentioned
particulars.
(G. RAMANJANEYULU)