himanshu patel

Himanshu Patel

**, ****** ******, **#*,

Jersey City, NJ 07306

Cell: 302-***-****

*********@*****.***

OBJECTIVE: Looking for Full / Part time Position as quality technician, associate scientist, laboratory supervisor, validation engineer or manufacturing operator in Pharmaceutical, Life science and Biotech industry.

STATUS: Permanent Resident- Eligible to work for any employer in the United States.

EDUCATION: Stevens Institute of Technology, Hoboken NJ

Master of Science in Pharmaceutical Manufacturing Engineering GPA 3.7

Major: Validation and Regulatory affairs

Coursework in Introduction to Pharmaceutical Manufacturing, GMP in Pharmaceutical Facility Design, Validation and Regulatory Affairs in Pharmaceutical Manufacturing, Contemporary Concepts in Pharmaceutical Validation, Pharmaceutical Finishing and Packaging Systems – Solid Dosage Forms, Design and Management of Sterile Pharmaceutical Manufacturing, Introduction to Project Management, Regulation and Compliance in Pharmaceutical Manufacturing, Quality in Pharmaceutical Manufacturing.

Presentations:

• Tablet manufacturing process

• Newer approaches in Pharmaceuticals

• Biogenerics

• Facility design for TDDS manufacturing facility

• Bid request package for Vial Washer

Certificates: Validation and Regulatory Affairs, Pharmaceutical Manufacturing Paractices

Projects: Development and Validation of cookie manufacturing process Apr 2009-May 2010

• Simulated manufacturing of cookies as a Solid dosage form and performed steps of manufacturing like weighing, blending, Granulation, Drying, Compression, Quality test and documentation according to FDA’s documentation requirement

• Reviewed, approved and revised SOPs, Training Records, Laboratory Reports, FMEA, Validation Master Plan, Quality Policy, Calibration and Maintenance Record, Master Batch Record, Process Flow Diagram, IQ, OQ, PQ, Cleaning Validation Protocol, Validation Reports

• Developed cleaning and blending process by DoE using statistical software MINITAB-15

• Prepared SOPs, Training Records, Quality policy, Quality Audit, Quality Audit Report

• Derived results, graphs using statistical software Minitab and identified sources of variation by interpreting graphs and results, Implemented investigation by using Root Cause Analysis tool and CAPA for the Non Conformance of the data

• Ensured that process and all documentation are as per cGMP regulation and no compliance issue is overlooked

Sardar Patel University, Gujarat India

Bachelor of Pharmacy, Secured third position in the university. GPA 3.9

Coursework and Practical Experience in Pharmaceutical Organic Chemistry, Pharmaceutical Inorganic Chemistry, Pharmaceutics, Pharmacology & Toxicology, Medicinal Chemistry, Microbiology, Pharmaceutical Analysis, Pharmacognosy, Biochemistry, Biopharmaceutics and Pharmacokinetics, Biotechnology, Physical Pharmacy, Physical Chemistry, Clinical and Hospital Pharmacy, Human anatomy and Physiology, Industrial Pharmacy.

SKILLS: Lab Skills:

• TOC Analyzer (Sievers 900), Swab Sampling , HPLC, Thin Layer Chromatography, Titration, Assay Analysis, UV Spectrophotometer, Omega Temperature Mapping Data Logger, PH Meter, Autoclave

• Raw Material Sampling, Equipment Calibration, Disintegration, Dissolution Apparatus, Analytical Balance, Tablet Manufacturing and Coating, Stability testing, QC tests for oral solid dosage form

• Microbiological Assays, Aseptic Techniques, Buffer and Media Preparation, Autoclave and Incubation, Sterilization

Regulatory Guidelines: Familiar with FDA (21 CFR), cGXP (GMP, GCP, GLP), ISO, EPA, OSHA, ICH, EMEA, Health Canada

Technical Skills: MS Office 2008– Word, Excel, PowerPoint, Project; Statistical Software-Minitab 15, M-files (Document Management System), Windows Xp/vista Operation and Troubleshooting

WORK EXPERIENCE:

Sarabhai Chemicals & Pharmaceuticals Ltd, Baroda, India Jan 2004-July 2007

Quality Control Technician:

• Implementation and writing of procedures (SOP) and responsible for technology transfers as per cGMP

• Quality testing and approval of raw materials for manufacturing and finished product

• Analyzed raw materials finished product stability studies and non-routine samples

• Performed In-process quality tests in quality control department

• Performed quality control tests for finished tablet, capsule and liquid dosage form

• Prepared Operational Qualification Protocols (OQ) of Blenders, Dryers, HPLC, GC, etc.

• Very familiar with Validation and Calibration of LC/MS, HPLC, GC, GCP, UV, UV/Vis, IR, KF

• Contributed in development of Master Validation Plan of the facility and reviewed, completed and revised SOP’s for the analytical Instruments

• Designed Acceptance Criteria for the Validation of the various instruments by using Design of Experiments(DoE)

• Part of the Root Cause Analysis team and CAPA for the investigation of the Non-conformance

• Analyzed interpreted and monitored Out of Specification (OOS) and Out of Trend (OOT) using Statistical Process Controls (SPC) like Control Charts and presented to upper management

• Familiar with method development and method Validation by performing lab and product Validations/Qualifications (IQ, OQ, PQ)

Osho Pharmaceuticals, Ltd, Ahmedabad, India June 2007-July 2008

Manufacturing Supervisor Trainee:

• Learned and supervised various processes in tablet manufacturing, including Weighing, blending, granulation, punching, and coating

• Trained in departments of sterile liquid solution, liquid manufacturing plant, filling line and packaging line

Emcure Pharmaceuticals USA, Inc, NJ USA June 2010-Dec 2010

Quality Control Technician Trainee:

• Performed quality control tests for various dosage forms as per cGMP

• Detailed knowledge of pre-formulation and formulation studies

• Familier with HPLC, UV, IR, GC, GCP

• IPQC tests for dosage forms

• Final product testing for solid dosage forms like, conventional tablets/capsules, Hard gelatin capsules, etc.

ACTIVITIES: Participated in Blood Donation & Thalassemia awareness camp organized by Indian Red Cross Society; Participated in National Convention of Indian Society of Technical Education; Volunteered for poor patient compliance survey in elderly patients, Member of ISPE

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