Address: ** ***** ***** ***** *******, NJ 07013
September 4TH, 2018 to May 2019
Certificate Program in pharmaceuticals Manufacturing Technology
New Jersey Institute of Technology-Newark, New jersey
July 2015 - April 2017
Master of Science in Organic Chemistry
K.K Shah Science College (Gujarat University) Ahmedabad, India
April 2012 - April 2015
Bachelor’s in chemistry (Gujarat university) Ahmedabad, India.
Experienced as a self-propelled professional in different areas of Pharmaceutical Industries i.e. Formulation and product development, Quality assurance and Quality control.
Familiar with solid and liquid dosage forms for immediate and sustained release such as tablets, capsules, powder, suspension and emulsion.
Proficient in Calibration of Analytical & Laboratory Instruments like UPLC, HPLC, UV, USP dissolution apparatus, Disintegration apparatus and KF.
Knowledge of applicable FDA regulations to Prescription, Generic and OTC drugs products.
Good understanding of (Module I, II, III and V of ANDA application) and NDA’s application.
Thorough understanding of 21 CFR part 11 (Electronic Records, Electronic Signatures and Audit trials), Part 210, 211, and 820.
Understanding of User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specifications (DS) and other critical system documentation.
Excellent experience in FDA regulated environments – GxP, cGMP, GLP, GCP and GDP.
Excellent understanding of the Software Development Lifecycle (SDLC) and QA Methodologies.
Practical experience of analytical testing of products as per cGMP and SOP.
Strong interpersonal, verbal and written communication skills
Possess the ability to work individually and as team member.
Computer System Validation: IQ, OQ, PQ, CAPA, Documentum.
Operating System: Microsoft Access, MS Office, MS Word, MS PowerPoint & MS Excel.
Proficient in Statistical Analytical Software (SAS).
Stallion pharma Bavala, G.I.D.C, Gujarat, India. (August 2017 to January 2018)
Quality Control Chemist
Performed analytical technique such as UV/VIS/HPLC/NMR/FTIR/Kalf Fisher/Spectophotometer and chromatographic techniques.
Follow cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices), GWP (Good Warehouse Practice).
Performed computer data entry, recorded production data, and volume produced consumption of raw materials.
Evaluate Physical-chemical characterization and formulation evaluation such as the measurement of solubility, dissolution, diffusion, tablet hardness, thickness, friability and Viscosity.
Tracked and monitored product quality and ensured compliance standards and specifications.
Maintained and tracked regulatory documents like batch records, analytical reports, temperature and humidly, assisted in evolution CAPA, deviation and change control.
Performed Wet Chemistry tests (i.e., Ph, viscosity etc.).
Research and gather information in a timely manner.
Prepare, label, organize and maintain laboratory notebook (LNB).
Granulation Technology Institute, Fairfield, NJ. Present
Quality Control Chemist
Operated and Calibrated of analytical instruments like UPLC, HPLC, UV spectrophotometer by using Empower software.
Involved in executing result from Dissolution apparatus and Disintegration apparatus.
Performed Wet Chemistry tests (i.e., ph., viscosity, titrations etc.).
Performed various pharmaceutical techniques extraction, distillation, titrations.
Data collection, interpretation, graph, report.
Solid understanding of GCP, GMP, GLP & SOP.
Performed validation, calibration, qualification and maintenance of laboratory instruments.
Prepared validation documentation for Process validation and Cleaning validation, Process study protocols and write a complete summary report after completion of Validation.
Prepared, labeled, organized and maintained record books.
Follow all SOPs referring 21 CFR Part 210, 211.