Vidhya Karanthamalai
Bangalore
Summary
Resourceful GCPQA with outstanding success liaising with senior management to define stakeholder needs, goals and objectives, articulate technical requirements and execute outcomes. Influences customers, suppliers and partners at account level. Highly proficient in molecular genetics, including advanced features to facilitate strong flow-charting and presentation skills. Adaptable Junior Manager with abilities in leading and managing projects without the supervision of management. Experience ensuring all projects are within budgets, on time and in accordance with business needs. Adept at managing a varied workload. Forward-thinking team leader skilled at operating departments efficiently to meet goals. Successful background matching employees with roles for maximum performance. Proactive and hardworking individual focused on continuous operational improvement.
Overview
6
6
years of professional experience
Work History
Junior Manager GCP QA
Syngene International Pvt Ltd
02.2022 - Current
- Conducting Internal Audit as per ISO1589:2022, NABL and Gap
- Responsible for supporting documentation work related to Internal Audits, Customer Audits and Regulatory requirements
- Daily QC activity verified as per the procedure
- Validation: Responsible for Instrument and equipment qualification in all divisions (IQ/OQ/PQ)
- Conducting Process, system audit and study specific audit as in GCP environment
- Handling Change control, deviation, observation as per the GxP Requirement, Regulatory requirements and implement the appropriate CAPA for the same through Trackwise
- Handling of QMS Related activity
- (Deviation)
- Responsible for ensuring the overall compliance of GxP Computerized systems at site
- Verifying the proficiency testing outcome, interlab comparison outcome (if applicable perform the root cause analysis)
- Documentation Review: Preparation, Review, distribution, and retrieval of SOP’s
- Review SOPs, IOPs method validation protocol, Method verification Report
- Review all documentation activity as per SOP’s
- Review, approve and retrieval of SOP’s in EDMS.
Research Associate – Oncology
Medgenome Labs Ltd.
03.2020 - Current
- Developed and validated an anti-SARS-CoV2 - IgG ,IgM & IgA (quantitative & Semi-quantitative) kit ( waiting for the ICMR approval)
- Handling assay development & troubleshooting of various internally developed assays
- Handling real-time PCR assays for KRAS, NRAS, BRAF & EGFR genes
- Handling digital droplet PCR assays
- Maintaining the Stock list and purchase of consumables and reagents
- Maintaining the biorepository of clinical samples
- Handling DNA/RNA Extraction of various types of clinical samples(automated and manual)
- FFPE (DNA,RNA), Blood RNA, CF-DNA Covid - 19 RT-PCR clinical samples successfully done the assay for more than 80000 samples
- QuantStudio 5.
Senior Executive – Molecular Genetics
Life Cell International Pvt. Ltd.
11.2018 - 02.2020
- Analyzed and reported single gene mutation (HBB, CFTR, G6PD, BTD, PAH, GALT, CAH) by Sanger sequencing method in disorders like beta thalassemia, cystic fibrosis of prenatal & postnatal clinical samples (over 5000 samples)
- Handled the Genetic analyser 3500 instrument
- Experience in chromosome microarray suite software for the analysis of prenatal and postnatal clinical samples successfully completed 100 samples
- Identified aneuploidies by quantitatively fluorescent tagged polymerase chain reaction (completed 50 samples)
- Analyzed and reported HUMAN PAPPILOMA VIRUS (HPV) and HUMAN PAPILOMA VIRUS by PCR and Sanger sequencing method (completed 3000 samples)
- MTB detection and MDR detection of MTB strains samples using Magpure 96 well from Roche (DNA isolation) (completed 900 samples)
- Successfully participated in NABL auditing for the accreditation of new panels in medical testing.
Research Associate
HELINI Biomolecules (Life Science Research)
09.2017 - 09.2018
- Conducted of laboratory testing according to procedures, preparing of intermediate materials, analytical test of intermediate materials and preventive maintenance of all laboratory equipment
- Documentation of all laboratory test records, equipment handling procedures and test procedures
- Managed Kits Validations, QC checking, Real-time PCR Kits, Pure past viral nucleic Acid Kits Preparation, Packing & dispatch the Materials
- Conducted DNA extraction from various biological samples using both solid-phase &solution-based DNA extraction methods
- Handled purification of virions and nucleocapsids of Baculovirus penaei (BP) of penaeid shrimp and subsequent extraction of the viral nucleic acid using spin column methods, micro RNA purification from human pathogen
- Detection of Antibiotic Resistance Genes in samples by Conventional PCR (Ephedra) ( MyGene Series peltier Thermal Cycler Corbett, Eppendorf)
- Identification of Human Enterovirus Serotypes by Use of a Reverse Transcription-PCR-Based Reverse Line Blot Hybridization Assay
- Acute-phase diagnosis of malaria, Dengue fever and scrub typhus using effective PCR methods.
Education
M.Sc. Biotechnology -
Alagappa University
04.2017
B.Sc. Zoology -
Alagappa Arts and Science College
04.2015
Skills
- Sanger Sequencing and data analysis
- COVID Sample handling
- Real-time PCR and data analysis
- ELISA
- Molecular Diagnostics
- Lab management
- Assay validation experiments
- Kit development
Languages
English
Tamil
Trainings, Workshops, Conferences And Seminars
- INTERNATIONAL CONFERENCE ON RECENT TRENDS IN BIOSCIENCE (ICRTB 2016), 7th & 9th April, 2016, Karaikudi, India
- NANOMATERIALS FOR SPECIALIZED APPLICATION (NMSA – 2017) & WORLD STANDARD DAY (WSD), 9th & 10th February, 2017, Karaikudi, India
References
- Ashok Kumar R, Assistant Manager, Fetomed laboratories Pvt. Ltd., marsashokkumar@gmail.com, +1(531) 2329072
- Dr. Gowri Shankar S G, Assistant Professor, Dept. of Biotechnology, Alagappa University, gowrishankar.alu@gmail.com, +91 9994933559
Technical Skills
ABI Genetic analyser 3500, Roche light Cycler 96, Roche light Cycler LC480, AriaMx System from Agilent Technologies, QuantStutio5, KingFisher, Tanbead, BioMek, ELISA reader, Digital droplet PCR, Sanger Sequencing, molecular diagnostic tests, Real time PCR Experiments (Taqman & SYBR Chemistry), Troubleshooting of Experiments etc., Bead based DNA/RNA extraction (manual and automated), ELISA experiments, Mutation Surveyor, Chromosome microarray suite software, Microsoft Office 2016, LIMS, Trackwise, EDMS, EQMS
Gene Bank Submission Details
Internal transcribed spacer region (ITS) sequence of Candida species isolated from clinical settings, MF445103, MF445104, MF445105, MF445106, MF445107, MF445108, MF445109, MF445110, MF445111, MF445112, MF445113, MF445114, MF445115, MF445116, MF445117, 07/08/2017, Gowrishankar,S., Vidhya,K. and Karutha Pandian,S.
Projects
Lupeol, a pentacyclictriterpenoid mitigate Candida species biofilms and virulent dimorphism, 12/2016, 06/2017, Lupeol, a non-toxic, pentacyclic triterpenoid was exploited for its ability to inhibit C. albicans and NCA species biofilm formation as well as reduce the viability of preformed biofilms. Effect of lupeol on C. albicans and NCA species biofilm formation was further visualized by SEM & CLSM, which revealed absence of hyphae, typical biofilm architecture and alteration in the morphology of biofilm cells.
Timeline
Junior Manager GCP QA
Syngene International Pvt Ltd
02.2022 - Current
Research Associate – Oncology
Medgenome Labs Ltd.
03.2020 - Current
Senior Executive – Molecular Genetics
Life Cell International Pvt. Ltd.
11.2018 - 02.2020
Research Associate
HELINI Biomolecules (Life Science Research)
09.2017 - 09.2018
M.Sc. Biotechnology -
Alagappa University
B.Sc. Zoology -
Alagappa Arts and Science College
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