Thiruneelakandan Gnanasambandan is seeking a challenging position in pharmaceuticals, medical devices, healthcare, or biosciences to utilize his skills in product and method development. He has over 5 years of experience in quality control and R&D, specializing in analytical method validation and transfer. He is skilled in HPLC, GC, UV, and titration methods and has experience managing quality teams and ensuring regulatory compliance. His most recent roles include method transfer specialist and quality control head at pharmaceutical companies in Singapore.

1. Page 1 of 5
RESUME
THIRUNEELAKANDAN GNANASAMBANDAN
BLK 283, Tohguan road, E-mail ID : thikar41088@gmail.com
#16-251, Singapore Phone No: 98837909
Pin: 600283 Alternate no: 91221072
OBJECTIVE
To seek a challenging position in the area of Pharmaceutical or medical device or Healthcare or
Biosciences to utilize my skills learnt in academic and industrial experience in diverse fields
including product development and method development.
COMPETENCIES
 Have strong Five years and Four months experience in QC and R&D in the field of analytical
development.
 Excellence in Method validation & Method transfer.
 In-depth knowledge in ISO 13485 standards & ISO 14971 standards.
 In-depth knowledge in CE regulations.
 Excellence in handling Empower & Labsoution softwares for HPLC methods.
 Endorsed in analytical testing by TamilNadu drug department for Eucare pharmaceuticals.
 Characterization of biological materials according to ASTM
 Able to manage QC activities.
 Calibration and maintenance of HPLC with PDA, UV-Visible spectroscopy and etc.,
 Knowledge in all functions of design and development department.
 Strong Knowledge in clinical analysis through literature route.
 Excellent in communication and presentation skill.
 Excellent in computer knowledge.
 Experienced in LIMS, QUMAS software’s.
Analytical Skills
 Full Compendial analysis for incoming raw materials.
 Assay by HPLC, GC, UV and Titration.
 Related substances by HPLC, GC, TLC & SDS page.
 Dissolution profiles using autosamplers. (Hanson & Disteck) by HPLC & UV.
 Moisture content, potentiometric titration, pH, Conductivity measurements.
 Analysis of Heavy metals as lead, Arsenic, iron, Copper, zinc and etc.,
 Purified water, raw water analysis & effluent water analysis as per IS standards.
 Identification techniques using IR, polarimeter, SDS-PAGE, TLC & wet chemistry.
 Viscoelastic properties using viscometers.

2. Page 2 of 5
PROFESSIONAL WORK EXPERIENCE
As a Method transfer / Validation Specialist: From Sep-2015 to Apr-2016 at ACTAVIS PAL.
 Validation of analytical methods (Assay, Related substances & Dissolution).
 Transfer of analytical methods from various sites.
 Performing stability analysis for various drug products.
 Reviewing the method transfer protocols & reports.
 Performing investigation analysis.
As a Quality Control Head: From Jun-2014 to Sep-2015 at Eucare pharmaceuticals.
 Handled a two major division which includes Chemical & Microbiology segments.
 Faced the Two CE periodical audit, Two ISO 13485 & 9001 audit and two WHO GMP
recertification audits.
 Prepared a BUDGET plan and managed the department in every aspect of capital and revenue
expenses.
 Investigated OOS, OOT as per MHRA requirements.
 Verified and approved the raw material and finished product reports before release.
 Prepared a specification, method validation documents.
 Equipment qualification during a lab shifting.
 Reporting stability trends to QA.
 Qualified a set of chemist and microbiologist for various functions.
 Carried out analytical method validation, fumigation validation & Cleaning validations.
 Conducted a periodical presentation in various fields.
 Updated the pharmacopoeia standards on regular basis.
 Harmonization of test methods from various standards.
As a quality control officer: Jan 2013 to Jun 2014 at Eucare pharmaceuticals.
 Carried out clinical research through literature route.
 Worked with risk management team for risk management application.
 Reviewed the analytical procedures
 Maintained the full stability studies for all set of products
 Implemented the traceability system in QC.
 Prepared set of quality plan with respect to the products.
 Performed release test for in process, raw material and finished product.
As a research and development analytical officer: From April 2012 to Jan-2013 at Eucare pharmaceuticals.
 Characterization of biological materials according to ASTM
 Developed a analytical methods and transferred the method to QC after validation.
 Conducted a release profiles for drug loaded products using HPLC.
 Made a research and development departmental flowchart
 Prepared a full set of design dossier from planning to design transfer

3. Page 3 of 5
 Worked in clinical research team for compliance.
 Handled a set of products as a product owner.
 Documented various tests performed on manufactured product.
 Develop Standard Operating procedures
 Designed a process control documents for various departments as per the USFDA regulations
 Participated in internal audit team as one of the internal auditor.
As a quality control officer: Jan 2011 to April 2012 at Eucare pharmaceuticals.
 Provide technical assistance to QA manager during the external audits operations.
 Proof read labels
 Prepared a analytical testing procedures
 Co-ordinate with R&D for test transfer.
 Created a GLP team for GLP & Schedule L1 Compliance
 Simplified the analytical procedures by colorimetric methods.
 Maintained the control samples
 Worked in HACCP team
 Performed raw material testing, raw water and effluent sample analysis.
As a XML trainee at Datamatrixes private limited Oct 2010 to Dec 2010
 Worked in Transformation and E-book projects.
STANDARD AND PHARMACOPOEIA UPDATES
Pharmacopoeia : IP, BP, EP & USP.
ISO Standards : ISO 9001:2008 - QMS; ISO 2859 – Sampling plan; ISO 17025-Quality control
requirements; ISO 11737- validation Bio-burden & Sterility; EN ISO 13485:2012 – Medical device QMS
& EN ISO 14971:2012 – Risk management.
WHO & ICH guidelines: in the field of stability studies, validation & technology transfer.
EDUCATIONAL QUALIFICATION
S.NO DEGREE COURSE
YEAR
OF
PASSING
INSTITUTION/
UNIVERSITY
PERCENTAGE
/ GRADE
1 Post graduate M.Sc Medical Sociology
Under
going
Madras
university
NA
2 Post graduate
P.G Diploma in Quality
Assurance and international
regulatory affairs
2012
Annamalai
university
59%
3 Under graduate B. Tech - Biotechnology 2010 Anna university 80%

4. Page 4 of 5
4 Diploma J2EE 2009 CSE A
5 Diploma C++ 2008 CSE A
6 HSC 12th 2006 State Board 75%
7 SSLC 10th 2004 State Board 78%
PROJECTS & ACHIEVEMENTS
 Analytical method validation for in-house methods
 Fumigation validation using virosil pharma.
 Cleaning validation by using clenzyme, Mosidet.
 Implementation of GLP, HACCP & Schedule L-1 concepts, as a head of SWG.
Title :Preparation of novel filter for absorbing nicotine from Cigarettes.
Duration : Six months ( final year project)
Title : Antibiotic resistant E.coli inhibited by siddha medicine.
Duration :Two month
Title : Characterization of Cucumber seedin comparison with other seeds
Duration : One month
INSTURMENT SKILLS
HPLC (Waters, Agilent, Shimadzu),Ion exchange Chromatography, Dissolution apparatus USP
(Hanson, Distek), PCR, Viscometer RVDV prime (Brookfield), SDS PAGE electrophoresis, , Potentiometer,
Moisture analyzer, UV Spectrophotometer, Thin layer chromatography, Sartorius balance, KFR automatic
titrator (Lasco), pH & conductivity meter.
Attended hands on Trained on: Differential scanning colorimeter (DSC) with TGA & DTA, Gas
chromatography, UTM and Texture analyzer.
COMPUTER SKILLS
• Possess good working knowledge of MSOffice, JAVA, C++ and J2EE.
Skilled in searching scientific data using various medical and pharmaceutical databases.
TRAINING
One day seminar on “Internal audit” by QSR system.
One week training on “Tune and prune your research” at shree chitra thirunal, Kerala.
One week hands on training in DSC, TGA & DTA at Madras IIT.

5. Page 5 of 5
One day seminar on “Water system” by Indian drug manufacturer association
One day seminar on “HPLC and Spectrophotometric methods” by Agilent technologies
One day programme on “Risk Management” by QSR consultants
GLP training for one day by Indian drug manufacturer association (IDMA).
One day training on stability studies conducted by Thermo labs
One week Training program on “Carrier development for industrial needs” at AAMCE Kovilveni
One day training on Red ribbon Club program.
One week training in dharani sugars and distilleries related full fermentation process.
PRESENTATIONS
Conducted a training in the following filed “GLP, personnel Hygiene, Chemical handling and safety”
Represented Quality control and R&D in Management review meetings.
Presented Biohazard in “Securza” at M.G.R university and won 2nd place.
“Cimefeast” at A.R.J.C.E.T and won 3rd place.
PERSONAL PROFILE
NAME :THIRUNEELAKANDAN. G
FATHER NAME : Ganasambandhan. S. K
DOB : 10:03:1989
GENDER : Male.
MARITAL STATUS : Single.
NATIONALITY : Indian.
LANGUAGES KNOWN : Tamil & English.
PERMANANT ADDRESS : Thiruneelakandan.G
3/33, Sivan koil steet. Amamchatram.
Kumbakonam-612103, Tamil Nadu - India
Passport number : L3674324
DECLARATION
Here by I declare above furnished details are true in my knowledge.
Signature
(Thiruneelakandan.G)