MALAY PATEL

Seeking a position to utilize my skills and abilities in the pharmaceuticals,Chemical,Food & testing Industries that differs the professional growth, while being resourceful, innovative and flexible. And to work with innovative & empowered team, which is constantly creating

A Talented & enthusiastic performer having impactful management skills with great deal of experience with GC & GC-MS method development & Validation, LC-MS & LCMS/MS method development & Validation. Done Nitrosamine activities on GCMS MS& LCMSMS. Genotoxic Impurities by Mass spectrometry , HPLC & UPLC. Validation GC Head-space method development & Analysis, GC Calibration, Wet Analysis (Specific optical rotation, IR, UV, Auto titrator, Karl-Fisher Apparatus etc), HPLC & UPLC development work and routine work & query work, TLC Method development & Validation & Documentation work & Particle size analysis, Flash Chromatography & other benchmark analytical activities.

• Certificate course in professional practices in Biotechnology
• Certificate course in professional practices in Bioinformatics

ALEMBIC VIDHYALAYA, VADODARA, GSEB, MAR-2005, 80.86

• Calibration of instruments
• Analysis of API, Intermediates & Raw Materials by Gas Chromatography
• Documentation of work
• Planning & reporting of work done
• Analyzing & improving method of determination & other parameters of API, Intermediate & Raw Materials
• Investigation of Unknown & Genotoxic impurities by GC/MS-MS.
• Other procurement & training work.
• Procurement of analytical instruments.
• Regular attending pre-scheduled training on Safety, cGMP & GDP & Personality development .
• To develop method to analyze purity & potency of API, RM, IM.
• To examine & Cover genotoxic impurities at different stages .
• To train & teach other chemist about development & other personal skills.
• Operation of Instruments with proper training of it for Qualitative & quantitative work.
• Preparation & performed Force degradation study & Validation with reports.
• To train & teach other chemist about development & other personal skills Planning & execution of day to day analytical Lab work .
• Execution of work of analysis on Different drugs & on its relative impurities for method development & analysis.
• USFDA, EDQM & Other agency Query related work to provide adequate documents with supporting proofs.
• Handling & Maintenance of instruments of my concern.
• Training on Technical & personal growth improving factor to enhance performance. Train sub coordinates .
• Outside company customer end support regarding technical query.
• Handling, Planning & execution of WET lab , Gas chromatographic lab, GC-MS & LC-MS Lab as incharge & reviewer.
• Working for method development & Quantification & Validation work on GC-MS & LC-MS.
• Preparing SOP for Calibration of Mass spectrometer.
• Method development & prevalidation of routine and genotoxic impurities on HPLC, GC & Mass spectrometer. Also doing method development for related substances, Assay and content methods.
• Impurity Purification & separation by Flash Chromatography.
• Preparation of Validation reports, COA & SOP and other procurement work .
• Nitrosamine Impurities (General) and other Genotoxic impurities method development & validation on GC-MS & LC-MS as per method. Also preparing report for method validation.
• Method development and validation on Particle size analyzer for varies drug substances & drug products.

• Date of Birth: 03/19/89
• Gender: MALE
• Marital Status: MARRIED