Project Manager Quality Control

Dhara Patel

** **** *****, **** **, Edison, NJ **816

Cell Phone: 201-***-****

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

OBJECTIVE

To obtain a position within a company that allows me to utilize my skills and experience in challenging

environment and that will enhance my skills and experience, and that allow me to serve to the best.

PROFESSIONAL EXPERIENCE

Hemispherx Biopharma, Inc., New Brunswick, NJ [June 2012 to Present]

Validation Specialist

• Perform Validation of Analytical Methods for identification and characterization of RNA polymer

intermediates.

• Conduct preparative and qualitative HPLC analysis on various protein and RNA samples.

• Perform Gas Chromatography for detection of residual solvent in samples.

• Develop and Validate GC, HPLC, UV Spectrophotometer and Ultracentrifuge based analysis methods

as per ICH guidelines.

• Prepare Standard Operating Procedures (SOPs), Standard Test Methods (STM), Validation Protocol

and final reports for validated methods.

• Use SIEVERS 900 TOC analyzer to find out purity of water samples.

• Write and modify test procedures through the plant document change process.

• Provide technical assistance and maintenance on related project duties, including release of product,

raw material and component as assigned.

• Provide assistance and facilitation in the support for assigned department and plant related projects.

• Maintain laboratory note books and documentation relevant to the assigned duties according to

GMP/GLP.

• Assist in investigation and documentation of laboratory investigations and Non-conformance reports.

• Participate in projects involving the Quality Control, including new method/equipment validations.

• Implement established Validation protocols and Standard Test Methods.

• Working knowledge of guidelines used in pharmaceutical manufacturing like cGMP, FDA and ICH.

•

• Stevens Pharmaceutical Research Center [Jan 2011 - Dec 2011]

• Laboratory Supervisor

•

• Wrote, executed and reviewed Validation Protocols, SOPs and Master Batch Records.

• Executed validation in mixing, tablet mfg., drying, temperature maintenance and cleaning.

• Optimization of various process parameters using statistical tools like DoE (Design Of Experiment),

Process Capability, Accuracy and Precision, Process control and Gage R&R using Minitab16

statistical software.

Dhara Patel

34 York Drive, Unit 6A, Edison, NJ 08816

Cell Phone: 201-***-****

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

• Performed Active Ingredient Recovery studies for tablets and Checked content uniformity of Final

products.

• Executed IQ, OQ and PQ protocols for manufacturing equipment at lab scale and Process Validation

protocol and documentation of each report including deviations.

• Prepared and maintained logbook according to cGMP standards.

• Worked as Project Manager for Internal Audit and Inspection of a cGMP laboratory.

• Reviewed and developed FMEA for design, process and equipment, developmental studies, SOPs, lab

reports and Risk Analysis documents, Root Cause Analysis, FAT, URS.

• Developed and Validate swab sampling method using TOC analyzer for cleaning validation.

• Used M-Files, an Electronic Documentation Management System (EDMS).

• Effectively managed laboratory resources and evaluated test results for product quality against

multiple specifications

•

• Biocare Remedies Private Limited, Gandhinagar, India [May 2008 - Dec 2009]

• Productions Supervisor and QA/QC Technician

•

• Managed and coordinated critical operations in manufacturing of solid, semi-solid and liquid dosage

forms.

• Executed validation Protocols (IQ/OQ/PQ) for new methods, cleaning validation and equipments

using standard methods in the operation areas.

• Prepared and maintained batch manufacturing records (BMR) for all finished products.

• Supervised the utilization of production and packaging instruments/equipment.

• Analyzed and resolved problems critical to production.

• Supervised, inspected and maintained production logbooks and other documentation as per cGMP &

ISO 9001 requirements.

• Performed testing of raw materials and finished products and labeled as passed, under test and

rejected.

• Assisted and facilitated in the development, implementation and execution of Test method validation.

• Involved in Root Cause Investigations, troubleshooting, problem solving and CAPAs.

•

• Planet Health India Ltd, Bopal, Ahmedabad, India [Feb 2008 - May

2008]

• Pharmacist

•

• Handled in-coming drug products

• Received and handled customers prescriptions and sold the drug products

• Organized drug products as per First In First Out (FIFO) rule

•

• Bombay Tablet Mfg Co. Private Ltd, Gandhinagar, India [Dec 20007 - Feb

2008]

• Pharmacy Trainee

•

• Observed and performed Q.C. tests and other production operations.

•

•

EDUCATION

Dhara Patel

34 York Drive, Unit 6A, Edison, NJ 08816

Cell Phone: 201-***-****

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

Master of Science in Pharmaceutical Manufacturing [Dec 2011]

Stevens Institute of Technology, Hoboken, NJ

Bachelor of Pharmacy [Dec 2007]

Rajiv Gandhi University of Health Sciences, Belgaum, India

•

• Certificates & Courses:

• Certification of Good Pharmaceutical Manufacturing Practices

• Certification of Validation and Regulatory Affairs

•

Activities

• Member of International Society of Pharmaceutical Engineers (ISPE)

SKILLS

• Laboratory Skills: TLC, titration and chemical and microbiological assays.

• Analytical Equipment: HPLC, TLC, GC, Sievers 900 TOC Analyzer, Gel Permeation

Chromatography, Gel Electrophoresis, P & ID Drawing, UV, UV/Visible Spectro-photometer,

Ultracentrifuge, Dissolution and Disintegration, titration and distillation instruments.

• Computer: EDMS (Electronic Document Management System)- M-Files, Statistical Software-

Minitab 15 & 16, Microsoft Project & Visio, Microsoft Office 2010, Windows ‘98/2000/XP/Vista

Prem/7.

• Other: Advances Root Cause Investigation, Track-Wise CAPA, Excellent communication and

technical writing skills, Extremely Organized, Meticulous, Enthusiastic and Strong Problem Solving

Skills, Self Motivated skills.

• Languages: English, Hindi, Gujarati.

REFERENCE

• Parul Dhruve – QC Lab Manager, Hemispherx Biopharma, INC.

• *****.******@**********.***

•

• Mayur Patel – QA Microbiologist, Ortho Clinical Diagnostics, a J & J Company

• *********@*****.***

Dhara Patel

34 York Drive, Unit 6A, Edison, NJ 08816

Cell Phone: 201-***-****

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

•

• Professor Dr. Leonid Shnayder- Stevens Institute of Technology, NJ

• ********@*******.***

•

• More References Available Upon Request

• Willing to Relocate

Contact this candidate