qa/qc

Dhruv Shah

** ******* ******, *** *, Jersey city, NJ 07306

Phone: 201-***-**** Email: shahdhruv21@gmail.com________________________________________

Objective: To obtain a challenging position in a pharmaceutical/biotech industry that enables me to utilize my education and skills.

Profile:

Good understanding of the analytical methods and troubleshooting of instruments.

Communicate ideas effectively, quick learner and good organizational skills.

Detail understanding of the cGMP requirements, GLP and 21 CFR Part 211

Skills:

Analytical Instrumentation: Knowledge of HPLC, GC, UV spectroscopy, TOC analyzer, pH meter, conductometer, Dissolution and Distillation apparatus, Karl Fisher, Hardness Tester, Differential Scanning Calorimeter, Moisture analyzer, Autoclave, centrifuge, Homogenizer.

Performed swab sampling for cleaning validation, assay test, limit test, sterility test, media and culture preparation

Validation: Process validation, cleaning validation, Prepare and execute IQ, OQ and PQ protocols. Knowledge of Risk Assessment tools, CAPA, Root cause analysis, FMEA.

Pharmaceutics: Formulation aspects of the dosage forms and drug delivery systems; Granulation, Manufacturing process, Pharmacokinetics and Biopharmaceutics.

Chemistry: Synthesis of organic compounds, qualitative and quantitative determination of compounds

Computer skills: Professional with MS office, Minitab-16: Statistical analysis tool, Track pro: Calibration management software and M-files: Electronic document management system.

Experience:

Stevens Pharmaceutical Research Center, Hoboken, NJ May 2011-Dec 2011

Validation Engineer:

• Calibration and qualification of the equipments.

• Prepare SOPs of the instruments.

• Prepared Validation protocol and validation master plan (IQ, OQ, PQ, Process validation protocol, validation report) for the project.

• FMEA, DOE, Method development and method validation

• Spreadsheet development and spreadsheet validation

• Developed and executed cleaning validation protocol by swab sampling method using Sievers 900 TOC analyzer.

• Statistical analysis of process using Minitab 16: Six pack process capability, Gage R&R, Histograms.

Kosha Laboratories Gujarat, India April 2009-Dec 2009

Assistant QC Chemist

• Performed quality control tests for in-process and finished products samples using equipments like HPLC, UV spectrophotometer, TOC analyzer, dissolution/disintegration, PH meter, Conductivity meter, and Moisture analyzer.

• Expertise of testing using wet chemistry, FTIR, TLC and Karl fisher

• Assisted in investigation and recommended corrective action.

• Calibration and troubleshooting of laboratory instruments.

• Prepare test solution and reagents required to conduct tests.

• Prepared and reviewed SOPs, Record keeping and data evaluation.

Acron Pharmaceuticals Gujarat, India May 2008-July2008

Intern

• Manufacturing of emulsion, suspension, tablets and capsules.

• Reviewed and maintained batch records.

• Learned principles behind formulation development.

Qualifications:

Stevens institute of technology, Hoboken, NJ 2010-2011

Master of Science in Pharmaceutical Manufacturing Engineering

Cumulative GPA: 3.7/4.0

Relevant Coursework: Validation and regulatory affairs, Good manufacturing practices, Quality in pharmaceutical manufacturing, Pharmaceutical finishing and packaging, Regulations and compliance in manufacturing, Contemporary concepts of validation, Design/mgt of sterile manufacturing, Engineering economics and cost analysis, Project management

Gujarat University, Gujarat, India 2005-2009

Bachelor of Pharmacy

Cumulative GPA: 3.4/4.0

Relevant coursework: Pharmacology, Pharmaceutics, Medicinal chemistry, Organic chemistry, pharmacokinetics and biopharmaceuticals, Pharmaceutical Analysis, Anatomy & Physiology, Clinical pharmacy and Microbiology

Projects:

• Performance Qualification of autoclave and oven

• Facility design of chemical APIs

• User requirement specifications for isolator purchase

• Nanoparticles drug delivery system

Certificate:

Validation and regulatory affairs

Reference:

Available upon request

Contact this candidate