Quality Control Development
Resume:
GOPALSAMY RANGASAMY
Email: abqr00@r.postjobfree.com
Address: 1504
City: Monmouth Junction
State: NJ
Zip: 08852
Country: USA
Phone: 513-***-****
Skill Level: Director
Salary Range: $50,000
Willing to Relocate
Primary Skills/Experience:
See Resume
Educational Background:
See Resume
Job History / Details:
GOPAL SAMY RANGASAMY
1504, Northumberland way,
Monmouth Junction,
New Jersey 08852.
abqr00@r.postjobfree.com
A challenging position which utilizes both my research and industrial experience in analytical chemistry.
Summary
Proficient in Analytical Method Development and routine, Stability studies and Release Analysis for ANDA & QC with effective troubleshooting skills and analytical problem solving capability consistently meeting timelines.
Seven years experience in Pharmaceutical Industry
Seven years hands on with
o Related substance, Assay, Cleaning and Dissolution method development
o Time optimized method validation and development of formulations.
o Analytical method evaluation as per pharmacopoeias/ vendor methods.
o Analytical method transfer from R&D Centre to production plants.
o Quality Control, hands on experience.
o Extensive experience in GLP and cGMP regulation and documentation activity
o Good knowledge and exposure in HPLC and GC with reputed softwares, Dissolution apparatus, UV-Vis spectrophotometer.
Good analytical, communication and interpersonal skills.
Good knowledge of compendia monographs and performs monograph test methods.
Planning and execution of work assignment for the assigned projects to meet the timelines
Experience bolstered by relevant education : M.Sc ( Chemistry) and B.Sc( Chemistry).
PROFESSIONAL EXPERIENCE
November 2012 Present: As Analytical R&D Chemist, Analytical Research and Development in Novel Laboratories, Somerset, New Jersey, USA dosage form manufacturing company.
HPLC Method development for sustained release products, solid dosage forms.
Stability sample analysis and Dissolution profile testing for ANDA products.
Method validation and Method Transfer by HPLC, Titrator and UV.
Establishment of GLP and Quality Control system for QC laboratory.
Instrument troubleshooting and maintenance skills.
Prepare and review Standard Operating Procedures, Test Procedures and templates in the form of record of analysis/analytical work sheet
Adept in scientific documentation, communication and presentation. Training chemists to carry out method validation and routine analysis.
Establishment of GLP and Quality Control system for QC laboratory.
PROFESSIONAL EXPERIENCE
November 2005 November 2012: Sr Research Analytical R&D Chemist, Analytical Research and Development in Ranbaxy Research laboratories ltd( R&D Centre), Gurgaon, New Delhi, India.
Responsible for developing analytical methods by HPLC for drug substances and formulations for regular ANDA filings in the US and for filings in Europe market.
Responsible for addressing queries/ deficiency notifications raised by regulatory authorities to support the approval process, serving on therapeutic are project teams to keep pace with companys initiatives.
Responsible for performing validation studies of analytical methods in compliance with regulatory bodies for the US/Europe market.
Responsible for training entry level/junior chemists in instrumental techniques used in analytical work.
Method development and validations in HPLC, UV, Dissolution etc. Assay, related substance, etc. for API and Drug products.
Stability sample analysis and Dissolution profile testing for ANDA product.
Execute Method Validation and develop test procedures.
Analysis of pharmaceutical raw materials as well as finished products as per USP,BP,IP.
Conduct installation of instruments and establishing the operating procedure for the same.
Calibration of instruments and maintaining calibration schedule records. Checking and maintaining of laboratory records.
Responsible for maintaining sound EHS working conditions, practice in his\her assigned areas.
Provide analytical support to and participate with QC.Training of designated QC personnel in new methods.
Compliance of GLP and established practices.
PROFESSIONAL EXPERIENCE
(November2003 Nov2005): Trainee Analytical R&D Chemist, Analytical Research and Development in Sami labs Ltd, Peenya,Bangalore,India( USA and japan dosage form manufacturing company.)
Responsible for analysis of Raw material drugs, process samples, finished products and samples for Formulation Development.
Responsible for maintaining Lab Notebooks and documents for the assigned projects.
Performed Calibration and Preventive Maintenance Procedure for HPLC, UV Spectrophotometer, Dissolution Apparatus and Weighing Balance as per the schedule.
Performed Analytical Method development and Validation of pharmaceutical drugs as per USP,IP,BP and ICH requirementsHPLC Method development for sustained release products, solid dosage forms.
Instrument troubleshooting and maintenance skills.
Adept in scientific documentation, communication and presentation. Training chemists to carry out method validation and routine analysis.
Establishment of GLP and Quality Control system for QC laboratory.
Software Knowledge and Instruments Handled
Empower network server software of Waters (Build 1154), Empower-1,2 network server software, Waters Millennium 32 (ver 3.2), Agilent LC 3D Chemstation (Rev. A 08.03), Metrohm autotitrator software Tiamo 836 and Tecan software Megallan5.
HPLC system (Waters, Agilent, Shimadzu), UV/Vis spectrophotometer (Shimadzu & Perkin Elmer, HP), GC ((Shimadzu & Perkin Elmer, Aglient).
M.sc Project work
(As part of the curriculum in M.Sc I have worked on the following projects).
Analysis of homologues of hydrocarbons by Gas Chromatographic(GC) Technique at Indira Gandhi Centre For Atomic Research (IGCAR), Kalpakam under the able guidance of the Dr.P.R.Vasudeva Rao, Associated Director, Chemical Group.
PAPERS PRESENTED IN REFEREED CONFERENCES
Participated in Two days National Level Work Shop in Industrial Metal Finishing and Electroplating at CIT, Coimbatore during July 2002 Participated in one day National Level Students Symposium on Water Pollution Cause, Consequences and Cures at REC, Trichy during October 2001.
EDUCATION
M.Sc. (Master of Science) in Chemistry 2003
Coimbatore Institute of Technology (affiliated to Bharathiar University)
Coimbatore, India.
B.Sc. ( Bachelor of Science) in Chemistry 2001
Sri Ramakrishna Mission Vidyalaya College (affiliated to Bharathiar University )
Coimbatore, India.
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