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Manager Quality

Location:
Singapore
Salary:
$5000
Posted:
October 16, 2019

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Resume:

EGANATHAN KALIYAMOORTHY

Indian, Male, Married, living in Singapore.

Born on: 02nd July 1983

Blk.337, Jurong East Ave-1 #10-1566, Singapore – 600337

adalm1@r.postjobfree.com

+65 96738745

OBJECTIVE

To secure full-time employment as a Chemist / Analytical Chemist, where I am able to contribute my relevant skills and knowledge to support the operational goals of the organization.

EDUCATION

M.Sc. in Chemistry Khadir Mohideen College (Bharathidasan University),

Adirampattinam, India- April 2006

B.Sc. in Chemistry Khadir Mohideen College (Bharathidasan University),

Adirampattinam, India- April 2004

WORK EXPERIENCE

Research Associate March 2015 – Present

Singapore Centre for Environmental and Life Science Engineering (SCELSE), National University of Singapore

Provide researchers with analytical support including sample preparation, analyses and data collection

Maintain records of research and lab operations; this includes documenting experimental research procedures and assisting with laboratory database management.

Perform routine test such as Volatile Fatty Acid Assay and Polyhydroxyalkanoates Assay and other chemical testing using GC and HPLC.

Testing of Nutrients (e.g. Phosphorous, Nitrogen) using Ion-Chromatography and Flow Injection Analyser (FIA).

Running the bio-reactors & regular monitoring.

Conduct training on handling of Analytical equipment like HPLC, GC, UV-VIS Spectrometer, IC, FIA, etc. for newly-hired staff and Students.

Laboratory Analyst June 2011 – February 2015

SGS Testing and Control Services, Singapore

Evaluation & testing of raw materials and finished drug product.

Stability studies and trend analysis for Pharmaceutical drug products.

Dissolution Profiling and comparative study of registration sample with established products.

Drug adulteration testing for Health supplements and herbal medicine.

Calibration and maintenance of Analytical Instruments.

Perform Process Validation, Method Validation and Method Transfer.

Maintain quality system according local SOP, GMP, and ISO 17025 requirements.

Resolve quality related deviations by performing Out-of-Specification investigation (OOS), Out- of-Trend Investigation (OOT) and Corrective & Preventive Actions (CAPA) in the timely manner.

Create and Validate the Excel Sheet for the Calculation of Test results.

Team leader, involved in conducting induction for newly-hired staff and Assistance, guidance & coaching of junior staff.

Work planning & coordination with upper management.

Quality Assurance review for the laboratory work performed

Rectifying issues encountered by team members through troubleshooting.

Junior Manager (QC) October 2010 – June 2011

Dr.Reddy’s Laboratories, Hyderabad, India.

Determine quality objectives, participate in development of quality strategy and quality directions.

To assure consistency validating new products. Developing and enforcing processes by providing documentation & leading and coaching QA & QC junior colleagues.

Ensure & maintain QC equipment in good conditions by performing routine checks.

Maintains and improves our product quality by system, compliance and surveillance audits.

Prepares documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.

To assure ongoing compliance with quality and industry regulatory requirements.

Quality Control Management staff January 2009 – September 2010

Cipla Ltd, Bangalore, India.

Work closely with others in a team environment within the Quality Control laboratory and act as an integral team member on multidisciplinary teams that provide support for Manufacturing and Product Development activities.

Complete activities in compliance to applicable company procedures, specifications, and compendia requirements in an efficient and high quality manner.

Perform testing, analysis and data reporting for test samples.

Execute analytical methods for testing on a variety of test samples including raw material, in-process/finished product, stability, validation, Process Development and R&D test samples.

Prepare and standardize laboratory reagents and test solutions.

Generate Calculation Sheet, Data Reports and Forms.

Operate, calibrate, perform preventative maintenance and when required trouble shoot and repair minor problems with Analytical Instrumentation.

Support and execute activities for test method validation and transfer. Participate in test method development.

Author, edit, and review technical reports, protocols, specifications and SOPs.

Participate in and/or lead independent and team based investigations.

Determine root causes for Out of Specification and Atypical test results. Develop, propose and monitor corrective actions.

Perform all work according to applicable safety procedures using good laboratory techniques and using safe operation of laboratory equipment.

Maintain regulatory compliance in instrumentation records, test result documentation, usage logbooks, maintenance logbooks and all other product or project specific documentation with particular attention to accurate record keeping.

Act as peer technical and quality assurance review for laboratory work performed.

SKILLS

Hands on experience in operational knowledge of analytical instrumentation such as

HPLC, GC, UPLC, IC, AAS, FIA, Dissolution apparatus FTIR, UV-VIS

Spectrophotometer, TOC and KF Titrator, wet chemistry techniques.

Maintenance and Calibration of Analytical Instruments such as HPLC, UPLC, UV, FT-IR,

Dissolution apparatus, pH meter and analytical balances.

Experienced in handling chromatography technique with the software such as Empower, Lab solution, Chemstation, Chromeleon and Data Interpretation.

Experienced in Method Validation, Method verification and Method transfer of analytical methods.

Performing a Qualitative and Quantitative tests which include analysis of water sample, pharma raw materials, API's, In-process and finished drug products.

Stability studies of drug products, maintain stability chart records and maintaining in and out flow of stability samples.

In depth working knowledge of cGMP, R&D, pharmacopoeia & regulatory requirements for testing and validation procedures

Documentation of all test results in compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

Good understanding of USP, FDA regulations and ICH guidelines.

Comfortable working both independently and as part of team.

INSTRUMENTS FAMILIARIZATION

High Performance Liquid Chromatography

(HPLC/UPLC with UV/VIS, RID, PDA detectors)

Agilent 1200 & 1100 Series with Chemstation & Chromeleon software.

Water system with Empower software.

Dionex with chromeleon software.

Shimadzu with LC Solution software

Gas Chromatochrophy(GC –FID)

Shimadzu with LC Solution software

PerkinElmer

Atomic Absorption Spectrophotometer

PerkinElmer–Analyst 400

Fourier Transform Infra-Red Spectrophotometer

PerkinElmer-Spectrum RX1

UV-Visible Spectrophotometer

Shimadzu 2450 & 1700 series.

Dissolution Tester with automatic UV-VIS

Varian, Sotax, Electrolab,Agilent, Labindia.

Flow Injection Analyzer

Lachat – Omnion Software

Ion- Chromatography

Dionex – Chromeleon software

TOC analyzer, Polari meter, Digital Karl Fischer Titrator and other Basic Analytical Instruments.

COMPUTER LITERACY

Certificate in Microsoft Office Applications (Word. Excel, PowerPoint)

On-line documentation through TQC (Total quality control), QCMS (Quality control Management system), LIMS, SAP and ERP.

REFERENCE

LAW YING YU

Senior Research Fellow

Singapore Centre for Environmental and Life Science Engineering (SCELSE), Nanyang Technological University, Singapore.

Email: adalm1@r.postjobfree.com

ROHAN WILLIAMS

Senior Research Fellow

Life Sciences Institute, National University of Singapore.

Email: adalm1@r.postjobfree.com



Contact this candidate