Key skills and knowledge areas:
ƒÞ Solid command of equipment, method, process and cleaning validation
ƒÞ Knowledge and experience of aseptic and solid dosage manufacturing.
ƒÞ Expertise in pharmaceutical manufacturing and maintaining quality of product
ƒÞ Process development and improvement
ƒÞ Knowledge of CFR, GCP and ICH guidelines
ƒÞ Excellent experience working in GXP environment.
ƒÞ Strong team collaboration skills. Work closely with team members to achieve quality goals
EDUCATION
Stevens Institute of Technology ¡V Hoboken, NJ
Master of Science in Pharmaceutical Manufacturing, GPA: 3.7, 12/2011
Completed Courses in Major:
ƒÞ Contemporary Concepts of Pharmaceutical Validation, Validation and Regulatory Affairs, Process Analytical Technology in Pharmaceutical operations, Quality in Pharmaceutical Industry, Regulation and Compliance in Pharmaceutical Industry, Project Management, GMP in Pharmaceutical Facility Design, Design and Management of Aseptic Pharmaceutical Manufacturing
Baroda College of Pharmacy¡V Gujarat, India
Bachelor of Pharmacy, GPA: 3.8, 06/2009
Completed Courses in Major:
ƒÞ Pharmaceutical Engineering, Biotechnology, Microbiology, Organic Chemistry, Pharmacology, Pharmaceutical analysis, Pharmaceutics, Biochemistry, Clinical Pharmacy, Pharmacovigliance
TECHNICAL SKILLS
„X Swab Sampling, Statistical Process Control, CAPA, Design of Experiment, Writing SOPs, Spreadsheet Validations, 21 CFR Part 11, Gap Analysis, Gage R & R, Process Capability, ICH Q8, Q9, Q10 and GMP requirement, Operation and troubleshooting of Sievers 900 TOC analyzer, DOE, TQM, Statistical Tolerance Analysis, Six Sigma, TOC, Visual inspection, Quality control
„X Proficiency in Microsoft Office 2007, MS Project
„X Minitab 16 and M-Files
„X Good Organizational skills, Writing, Communication and decision taking skill, and interact with others effectively
WORK EXPERIENCE
DPT Labs, San Antonio, TX (August 2012-Present)
Permanent Validation Engineer
„X Compile validation protocols and reports, analyze results and prepare summaries of the data to support tests and protocol requirements
„X Lead execution, data interpretation and validation report writing
„X Perform extensive technical reviews and interpret data for accuracy of equipment/process performance for completed validations/revalidations
„X Provide technical support and guidance to manufacturing personnel during the execution of processed validation runs
„X Provides technical support to addressed deviations
„X Technical troubleshooting during validation runs
„X Work closely with all departments and consultants for timely execution of validation tasks
CVS Pharmacy, Milford, CT (December 2010-August 2012)
Full Time Pharmacy Technician
„X Direct handling of Prescriptions, maintaining Inventory, helping patients on phone and picking up, pulling and sending out recalls, doing out-dates and cycle counts, out of stocks, dealing with insurance companies and doctors.
Stevens Pharmaceutical Research Center, Hoboken, New Jersey (August 2010 - December 2011)
Qualification/Validation Project- Research Assistant, Lab Supervisor
„X Maintained and calibrated all equipment as per 21 CFR 211.68
„X Equipment and Process validation and Cleaning validation
„X Prepared Validation Master Plan, Cleaning Validation Protocol and Process Validation Protocol for Simulated product
„X Prepared and Executed of IQ, OQ and PQ of major Equipment
„X Prepared Protocol for Validation of Content Uniformity Spread Sheet
„X Developed, manufactured and validated Simulated Pharmaceutical Product to assure reliability of Product
„X Performed project using Stat...
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