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Quality Control Manager

Location:
Austin, Texas, United States
Salary:
$35000 - $90000
Posted:
October 12, 2016

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Yogesh B. Thakur

Master of science

**** ****** ***** ****** ***** – 78727 United State of America Phone: +1-512-***-****

Email: acw0ky@r.postjobfree.com, acw0ky@r.postjobfree.com Skype Id: yogesh3982

Analytical Scientist/Chemist Analytical Development & Quality Control Lab Pharmaceutical Industry

PROFESSIONAL SUMMARY

Shouldered the role of Manager – Analytical Method Development at Flamingo pharmaceuticals Limited, New Mumbai - India.

Master of Science with FDA Approval in Instrumental & Chemical Sciences with more than 10 years of rich experience in analytical development and quality control of finished products (Tablets, Capsules-HG/SG, Injectable, Suspensions, Nasal Sprays, MDI & DPI Inhaler’s, Nasal Solutions, Suppositories, Creams, Ointments, Gel, Foam and Syrups) and APIs.

Pursuing Diploma in Drugs Regulatory Affairs from the Institute of Pharmaceutical Education and Research.

Sound knowledge on analytical method developments, method validations, impurity profiling, technology transfer, quality & regulatory and knowledge of cGMP, USFDA, EDQM, ICH, JP guidelines.

Faced audit - MHRA-UK, US FDA, TGA-Australia, WHO-UNICEF, MCC-South Africa, FDA-India and vendor Audits.

Skills/Competences: Team management, GLP systems, audit & compliance, trainings & presentations, analytical method development and validations, force degradation, method transfer, stability studies, dissolution studies, analyst validation, calibration & maintenance etc.

AREAS OF EXPERTISE

Team training and monitoring

Quality assurances standards

Hands on experience in analytical techniques

Analytical method development and validation

EDUCATION

Diploma (Drugs Regulatory Affairs)

:

Institute of Pharmaceutical Education and Research, Pune, India (June 2016 – Pursuing)

Master of Science

(In-organic chemistry)

:

University of Mumbai, The Institute of Science, Mumbai, India (June 2003 – June 2005)

Bachelor of Science

(Chemistry)

:

University of Mumbai, CKT College Panvel, Mumbai, India (June 2003 – June 2003)

WORK EXPERIENCE - CAREER PATH

Manager – AMD at Flamingo Pharmaceutical Limited, New Mumbai, India

October 2015 – January 2016 (3 months)

Led analytical method development and method validation teams.

Supervised and co-ordinated with different analytical teams at different location.

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.

Scientist - Quality Research Lab at Ningbo Menovo Pharmaceutical Limited, China

July 2014 – September 2015 (1 year 2 months)

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.

Accomplishments at Menovo Pharmaceuticals Ltd

Successfully implemented GLP system in the laboratory.

Successfully implemented Good documentation practices in the laboratory.

Senior Supervisor – ADL at Merck Limited, Nerul, New Mumbai - India

July 2008 – July 2014 (6 year)

Led analytical development group effectively.

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.

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.

Accomplishments at Merck Ltd

Successful development & transferred number of analytical methods under cGMP environment.

Successfully handle the project of transferring various injectable from IM to IV.

Actively handled role of ADL representative while process validation at toll manufacturing units.

Supported for dosser filling during the tenure.

Section Head – Finished Product Quality Control Lab at Cipla Limited, Patalganga, India

May 2005 – July 2008 (3 year 2 months)

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.

PRESENTATIONS

Delivered PowerPoint Presentation on ICH Q3A - impurities in new drugs substance, ICH Q1A - stability testing, ICH Q2A - analytical method validation and ICH Q3C - Residual solvents.

Computers & Its Applications To Chemistry: Project Submitted To Institute Of Science Mumbai.

INSTRUMENT HANDLED

HPLC (LC solution, Chomeleon, Chemstation & Empower), GC, Brookfield Viscometer, Dissolution Test Apparatus, Potentiometer, FTIR, Karl Fischer Apparatus, Polarimeter, IR Moisture Balance, UV, AAS, DT Apparatus, Osmometer, Dissolution Media Preparator, Flame Photometer, Refractometer, LCMS & ICP.

PERSONAL DETAILS

Date of Birth : September 03, 1982

Nationality : Indian

Language Skills : English, Hindi and Marathi

Web site : http://yogesh3982.branded.me/

LinkedIn Profile : https://www.linkedin.com/in/yogesh-thakur-25a12b16



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