Highlights: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.

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.

Certification:FDA Approval in instrumental & chemical sciences - Mumbai (Thane) India.

Manager - Analytical Method Development 10/2015 - 01/2016
Flamingo Pharmaceuticals Ltd. India, panvel, maharashtra India
Industry: Pharmaceuticals
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.--
Scientist - Quality Research Lab 07/2014 - 09/2015
Ningbo Menovo Pharmaceuticals Ltd. China, Hangzhou, zhejang China
Industry: Pharmaceuticals
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.--
Sr. Supervisor - Analytical Development Lab 07/2008 - 07/2014
MerckLtd, India, Mumbai, maharashtra India
Industry: Pharmaceuticals
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.--
QC Chemist, Section Head - Finished product QC 05/2005 - 07/2008
Cipla Ltd, India, Mumbai (ptg), India., maharashtra India
Industry: Pharmaceuticals
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.--

University of Mumbai 06/2000 - 06/2003
Mumbai, maharashtra, India
Degree: Bachelor's Degree
Major:Chemistry
Completed BSc from the CKT college Panvel. Major subject: Chemistry

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