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Yogesh Thakur

Contact Yogesh Thakur
Phone: verified employer only
Email: verified employer only
Web/Blog http://yogesh3982.branded.me/
Street: verified employer only
From: Austin, Texas 78729 United States
Visa Status: H4 Visa (Require H1b VISA)
Languages Spoken: English, Hindi, Marathi
Interests/Hobbies: Playing cricket and reading

Career Profile

Degree: Master's Degree
Career Level: Experienced
Occupation: Life, Physical, and Social science
Career Title: Chemists
Target Title: Analytical chemist, Scientist, Quality control chemist, analyst
Target Locations: austin, TX , new york, NY, New Jersey, Ohio, Florida, , philadelphia, PA, Anywhere in USA
Skills: Analytical method development; Method validation; Method transfer; Analytical chemist; Analytical Scientist; Stability Studies; Hplc; Dissolution; Team Training & presentation; Analytical techniques; Quality control; GLP system; audit & compliance; trainings & presentations; Team management; analyst validation; calibration & maintenance;
Goal: I am seeking a challenging assignment where my knowledge and practical skills can benefit an organization that is positioned for growth. That position offering opportunity to explore my qualification, experience and skills in the area of quality control, research and development in analytical field.
HighLight: Successfully worked on numbers of official & in-house drug products & combinations products including range of drugs, multivitamins, harmon’s & steroids etc; from the stage of analytical method development, force degradation, pre-formulation, method validation, stability studies, etc to analytical method transfer to Quality Control.
Certification: FDA Approval in instrumental & chemical sciences - Mumbai (Thane) India.
Reference: verified employer only
Yogesh Thakur is Analytical chemist, Scientist, Quality control chemist, analyst(Life, Physical, and Social science) from Austin,Texas United States.

Experience


Flamingo Pharmaceuticals Ltd. India panvel, maharashtra India
Industry: Pharmaceuticals
10/2015 - 01/2016
Manager - Analytical Method Development
Shouldered the role of Manager – Analytical Method Development at Flamingo pharmaceuticals Limited, New Mumbai - India. Sound knowledge on analytical method developments, method validations, impurity profiling, technology transfer, quality & regulatory and knowledge of cGMP, USFDA, EDQM, ICH, JP guidelines.
• Led analytical method development and method validation teams. • Performed work allocation, follow-ups and assign individual work responsibilities and accountability. • Training, development and implementation of GLP system in the laboratory. • Conducting internal audits, QA/QC rounds, safety rounds. • Handling regulatory queries and requirements. • Co-ordination with QA, regulatory, QC & R&D for data compilation. • Project planning, technology transfer planning & review. • Drafting & reviewing protocols & reports for method validation, forced degradation, stability testing, technology transfer, analyst validation etc. • Development & optimization of analytical method; support R&D for speedy development process.
Ningbo Menovo Pharmaceuticals Ltd. China Hangzhou, zhejang China
Industry: Pharmaceuticals
07/2014 - 09/2015
Scientist - Quality Research Lab
Shouldered the team leader position for the Analytical method development and validation.
• Performed work allocation, follow-ups and assign individual work responsibilities and accountability. • Training, development and implementation of GLP system in the laboratory. • Conducted internal audits, QA/QC rounds, safety rounds. • Handled regulatory queries and requirements. • Co-ordinated with QA, regulatory, QC & R&D for data compilation. • Drafted & reviewed protocols & reports for method validation, forced degradation, stability testing, technology transfer, analyst validation etc. • Developed & optimized of analytical method; support R&D for speedy development process. • Reviewed calibration of instruments, OOC and column performance, OOS/OOT investigation, Laboratory Incident, deviation & change control.
MerckLtd, India Mumbai, maharashtra India
Industry: Pharmaceuticals
07/2008 - 07/2014
Sr. Supervisor - Analytical Development Lab
Handled the role of Senior supervisor for analytical development lab, supervised the activities of analytical method development, validation, stability studies, tech transfer and process validation.
• Trained chemists, QC supervisors and chemists on relevant procedures for smooth execution of projects and improve efficiency. • Analytical tech-transfer from ADL to QC labs - pilot-plants, commercial sites, third party manufacturing sites under strict cGMP environment. • Drafted and Reviewed analytical method validation, force degradation studies, analytical method transfer, stability studies, standard test procedures (STP) & development documents etc. • Developed and validated analytical method for new & existing formulations using modern analytical techniques for various mandatory tests such as assay, dissolution & related substances. • Worked for the P2P products, OTC products, competitor’s sample, parties query samples & market complaint sample. • Shouldered responsibilities of maintaining stock of instrument spares, laboratory chemicals and reagent. • Delivered trainings and presentations, contributed in developing and implementing cGLP system in the laboratory. • Shouldered responsibilities of calibration, preventive maintenance and service planner and troubleshooting of instruments such as HPLC, dissolution apparatus, DT apparatus, FTIR, friabilator, pH meter, balance, Merck millipore, dissolution media preparator, etc. • Linked with QA, QC and F & D for data compilation. • Involved in setting up new analytical laboratory to handle activities and documentation like IQ/OQ/PQ and SOPs.
Cipla Ltd, India Mumbai (ptg), India., maharashtra India
Industry: Pharmaceuticals
05/2005 - 07/2008
QC Chemist, Section Head - Finished product QC
Supervised the activities within the finished product section and reviewing analytical reports.
• Co-ordinated with production, Microbiology lab, QA & store for batch release and dispatch. • Handled responsibilities of Calibration, troubleshooting of instruments, drafting of incident, OOS/OOT investigation, deviation & change control. • Worked on various types of finished products, party’s query samples & complaint samples. • Handled responsibility of online-Sampling-packaging-line inspection, up-keeping & destruction of reserved sample and under analysis sample. • Involved in the development of LIMS Sapphire software. Accomplishments at cipla Ltd • Strictly followed the timeline and priority for QC released. • Successfully resolved party’s analytical query.

Education


University of Mumbai Mumbai, maharashtra, India
06/2000 - 06/2003
Degree: Bachelor's Degree
Major:Chemistry
Completed BSc from the CKT college Panvel. Major subject: Chemistry
University of Mumbai Mumbai, maharashtra, United States
06/2003 - 06/2005
Degree: Master's Degree
Major:In-organic chemistry
Completed MSc from the Institute of Science, Mumbai. Major subject: In-organic Chemistry
Institute of pharmaceutical education and research Pune india , maharashtra , India
06/2016 - current
Degree: Professional Degree
Major:Drug regulatory affairs
pursuing Diploma in Drugs Regulatory affairs.

Resume(verified employer only)

Chemist Software Testing Pharmaceutical, Software testing, HPLC, chemist, scientist
Resume_Yogesh HPLC, Analytical scientist, ARD, Quality control, chemist

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