VASANTHA LAKSHMI H.

G
+91 8861989757, 9916594594.
vasantha8861@rediffmail.com

Objective

 I would like to work and grow in an environment, where performance is rewarded with new
responsibilities, and serve in a reputed growth oriented Industry in the field of
Pharmaceutical, Development and Maintenance to power my career ahead.

Professional Summery

 Master of Science with Around 12 years experience in reputed GMP Regulated and Export
Oriented Pharmaceutical industries in Quality Control.

Presently working in:

 5.0 Lake chemicals pvt ltd
: EU-GMP
Duration : Feb - 2018 to Till date
Designation : Assistant Manager
Current Job Profile:
 Planning and execution of Quality control activities on daily basis
 Training of quality control persons to meet GLP
 Supporting to quality assurance, production during process validation
 Preparing specification, SOPs and relevant documents as well as undertaking
analytical method validation and related documents.
 Supervising analytical work & documentation as per pharmaceutical industry
regulations (CGMP) various regulatory authorities.
 Preparing Certificate of Analysis, Working standard profile, Method of analysis and
specifications for Key Raw materials, in process controls, Intermediates and final .
 Reviewing documents /analytical reports thereby ensuring documentation as per
guidelines.
 Implementation of good laboratory practices,
 Co-coordinating with internal and external auditors and customers.
 Review the new product Specification and Method of analysis.
 Review of COA’s.
 Handling of customer complaints and requirements.
 Supervising system audit, Management of Incidents, Deviations, Change controls and CAPA
,OOS,OOT.
 Stability analysis review and handling issues.
 Key Auditee various customer audits.

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 VASANTHA LAKSHMI H.G
+91 8861989757, 9916594594.
vasantha8861@rediffmail.com

Previously worked in:

 4.0 Ce-Chem pharmaceuticals pvt ltd

: WHO-GMP

Duration : Feb - 2017 to Nov 2017

Designation : Head QC
Current Job Profile:
 Planning and execution of Quality control activities on daily basis
 Training of quality control persons to meet GLP
 Supporting to quality assurance, production during process validation
 Preparing specification, SOPs and relevant documents as well as undertaking
analytical method validation and related documents.
 Supervising analytical work & documentation as per pharmaceutical industry
regulations (CGMP) various regulatory authorities.
 Preparing Certificate of Analysis, Working standard profile, Method of analysis and
specifications for Raw materials, in process controls, Intermediates and API.
 Reviewing documents /analytical reports thereby ensuring documentation as per
guidelines and preparing Analytical technology package for the developed processes.
 Implementation of good laboratory practices
 Co-coordinating with internal and external auditors and customers.
 Review the new product Specification and Method of analysis.
 Review of COA’s
 Implementation of cGMP
 Handling of customer complaints and requirements.
 Training and qualification of Analyst thru competent skill matrix.

3.0 Micro Labs Ltd,Hosur,

- Approved by WHO
Duration : August - 2015 to August 2016
Designation : Executive–Analytical validation department.
Current Job Profile:

 Testing of different formulations such as tablets (Film coated, sugar coated and Enteric
coated), capsules and suspensions, samples by chemical and instrumental methods and
interpretation of results by using current approved methods.
 Carry out the Analysis of Stability of Drug Products like Tablets, Hard Gelatin Capsules
& Soft Gelatin Capsules as per Protocol
 Calibration of analytical instruments Like HPLC, UVspectrometer and Dissolution
apparatus.

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 VASANTHA LAKSHMI H.G
+91 8861989757, 9916594594.
vasantha8861@rediffmail.com

 Documentation of log books, calibration records, temperature and humidity records etc.
 Recognizes out of specification (OOS, OOT) results and completion of lab investigations.
 Testing of Hold time study, In-process sample.
 Reviews of analysis reports and quality control records.

 Review the new product Specification and Method of analysis.

 2.0 Stabicon life sciences pvt ltd Bangalore, India.

- Approved by USFDA, WHO &Canada Health,NABL.
Duration : April -2014 June -2015.
Designation : Executive - Quality Control and project management
Job Profile:
 Carry out the Analysis of Stability of Drug Products like Tablets, Hard Gelatin Capsules &
Soft Gelatin Capsules as per Protocol.
 Performing Assay, Related substances, Identification, Dissolution, Content of uniformity,
Disintegration, Melting range, Moister Content, Loss on Drying, Standardization, Titration
& Extractions.
 Calibration of all Analytical Instruments and maintenance of calibration records.

 Preparing protocols for comparative dissolution profile method validation, method

transfer
 Maintenance of Chambers & HPLC Columns &all other GLP Activities.

 1..0 NATURAL REMEDIES PVT LTD Bangalore,

- Approved by NABL.
Duration : Feb – 2006 to April - 2014
Designation : Senior research assistant - Quality Control.

Job Profile:

 Identification &Quantification of Bioactive & Phytochemical Compound by Hptlc,UV

Visible Spectrophotometry , Hplc, GC & IR.
 Calibration of all Analytical Instruments and maintenance of calibration records.
 Carry out the Analysis of finished products like Tablets, Hard Gelatin Capsules and
market complaint samples as per method of analysis.

 Performing Assay, Melting range, Moister Content, Loss on Drying, Standardization,

Titration & Extractions.

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 VASANTHA LAKSHMI H.G
+91 8861989757, 9916594594.
vasantha8861@rediffmail.com

 Preparation and certification of Working Standards.

 Preparation and Review of SOP’s, STP’s, COA’s etc.
 Documentation of log books, calibration records, temperature and humidity records etc.
 Instruments Handled
Chromatography:
 HPLC_Waters-Alliance 2695 with Empower-3 Software.
 HPLC_Shimadzu-2010A HT with LC Solutions & Class-VP Software.
 HPLC_Agilent-1290 with ChemStation Software.
 GC_Shimadzu-2010 with GC Solutions Software.
 Ptominence i-2030 C
Spectrophotometer:
 UV Spectrophotometer_Shimadzu with UV Solutions Software.
 FTIR_Shimadzu with IR Solutions Software.
 Polarimeter_Rudolph Analytical
Dissolution:
 Electro Lab & Lab India.
Disintegration:
 Electro Lab & Lab India.
KF Titrator:
 MetrohmTechnical Qualifications:
 Good knowledge in computer.

Competencies:
 Having the exposure to Customer & regulatory audits like, WHO, NABL, Uganda-MOH,
Kenya-MOH, Sudan-MOH, EU GMP.
 Good written communication and presentation skills.
 Work effectively with diverse groups of people.
 Ability to work at any situation, Hardworking.

Academic Profile
 M.Sc.-Life Science from KuvempuUniversity with First class (65%).
 B.Sc. –Chemistry, Botany, Zoology from KuvempuUniversity with First Class (62%).
Area of Interest: Quality assurance, analytical quality assurance(Interested in handling of QMS
activities) and regulatory affairs and quality control.

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 VASANTHA LAKSHMI H.G
+91 8861989757, 9916594594.
vasantha8861@rediffmail.com

Personal profile:

Name : Vasantha Lakshmi

Father’s Name : Govindan H.S
Marital status : Single
Languages known : English, Hindi, & Kannada.
Nationality : Indian.
Permanent Address : NO-436, Opposite to sarvana bungalow
Anekal road, Attibele,
Bangalore -562107

Declaration:
I hereby declare that the information mentioned above is true to the best of my knowledge and I
will abide the rules and regulations of your concern if you given a chance.

Date

Place: Bangalore Vasantha Lakshmi

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VASANTHA LAKSHMI H.G
+91 8861989757, 9916594594.
vasantha8861@rediffmail.com

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