Quality Control Manufacturing

Himanshu Patel

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

Jersey City, NJ 07306

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

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

OBJECTIVE: High potential 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

Sardar Patel University, Gujarat India

Bachelor of Pharmacy with Chemistry major,

Secured third position in the university.

GPA

3.9

WORK EXPERIENCE:

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

. Wet Chemistry, Stability Testing

. Validation and Qualifications

. Cleaning Validation and Method Validation

. Validation Reports

. IQ, OQ, PQ

. Detailed knowledge of pre-formulation and formulation

studies

. HPLC, UV, IR, GC

. IPQC (In Process Quality Control) tests for dosage forms

. Final product testing for solid dosage forms like,

conventional tablets/capsules, hard gelatin capsules, etc.

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

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 (Emulsion)

. Analytical and Microbial Assay

. R & D of new tissue forms

. Biomechanical properties of allograft tissue

. Sterile Processing

. SDS-PAGE, ELISA

. Analytical Biochemistry Methods

. Prepared Operational Qualification Protocols (OQ) of

Blenders, Dryers, HPLC, GC, etc.

. 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)

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

SKILLS: Lab Skills:

. Wet Chemistry, TOC Analyzer (Sievers 900), Swab Sampling,

Osmolarity, HPLC, FTIR, Thin Layer Chromatography,

Titration, Assay Analysis, UV Spectrophotometer, NMR,

Omega Temperature Mapping Data Logger, PH Meter,

Brookfield Viscometer, White Light, 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, Bioburden, Aseptic Techniques,

LAL, Concentration, Buffer and Media Preparation,

Autoclave and Incubation, Sterilization

Regulatory Guidelines:

FDA (21 CFR), cGXP (GMP, GCP, GLP), ISO, EPA, OSHA, ICH,

EMEA, ASTM, Health Canada

Technical Skills:

MS Office 2008- Word, Excel, PowerPoint, Project;

Statistical Software-Minitab 15, M-files (Document

Management System)

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