Quality Assurance Manager

DIPENKUMAR BHORANIA

*** ******* ******, *** *

Jersey City, NJ-07306

Cell 201-***-****

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

OBJECTIVE: Seeking a position within a company where professional

experience, education and abilities stand as an advantage

for personal growth.

EDUCATION: Stevens Institute of Technology, Hoboken, New Jersey

May 2010

Master of Science in Pharmaceutical Manufacturing

GPA: 3.6

Rajiv Gandhi University of Health &

Science, Karnataka, India Oct 2007

Bachelor of Pharmacy

GPA: 3.62

Major Subjects:

Quality Assurance in Pharmaceutical Manufacturing,

Validation and Regulatory Affairs, Cleaning validation,

NDA, ANDA and IND Applications,, cGMP Guidelines & FDA

regulation, Pharmaceutical Packaging and Finishing,

Pharmaceutical Facility Design,, Pharmaceutical Organic &

Inorganic Chemistry, Applied Biochemistry, Pharmaceutical

Analysis, Project Management, Bioprocess Pharmacology,

Pharmaceutical Engineering, Pharmaceutical Biotechnology,

Pharmacokinetic & Therapeutic Drug Monitoring, Lean

manufacturing and QSR, Engineering Economics and Cost

Analysis.

SKILLS: Lab skills: Sterile Technique, Physical

Testing of tablets, Raw material Sampling,

Pippeting Preparation of Chemical Solutions

Determination of water Content, Gram and Acid fast

Staining, Granulation, Centrifugation,

Disintegration and Dissolution.

Instruments: KF Titrator, Potentiometer,

Polari meter, pH meter.

Equipments: Bottle and Syringe

Fillers, Tablet Press, Ball Mill.

Software: Adobe Photoshop, Microsoft office, Microsoft

Project, Minitab.

Analytical: HPLC, Mass Spectrometry, IR Spectroscopy, UV

Spectroscopy.

Other: Excellent verbal communication skill, good

understanding of cGMP, self motivated.

WORK

EXPERIENCE: Pfizer Inc, Pearl River, NY

Lead Aseptic Technician:

March 2011 - Present

. Working in the Vial Filler Room with Aseptic Gowning.

Filling of vials and maintain all the records in the

PBR and troubleshoot any alarms in the vial filler.

Collect and maintain the SCADA report, stopper

sterilization chart and all the supportive docs with

the PBR.

. Oversee the activities takes place in the vial washer

and sterilization tunnel area. Make proper and

effective schedule for the formulation, production,

inspection and packaging.

. Train and manage new employees in all departments and

keep and track their training records. Assist

supervisor in reviewing and updating the SOPs.

. Also work in vial inspection and packaging area and

hands on Eisai Inspection Machine, Nikka-Densok

Pinhole Inspector, IMA Libra Labeler and Cartoner.

. Performed CIP, SIP, Filler parts set-up, Filter

integrity testing, Line clearance, Actual filling, In

Process Check Weigh, end of fill activities like

Reconciliation, Glove Integrity testing etc.

. Performed Washing and Sterilization of vials in the

Inova Vial Washer and Depyrogenation tunnel and

document it in the PBR.

. Identify any problems and downtimes in the filler and

suggest proper corrective actions.

DPT Laboratory, Lakewood, NJ

Formulation Aseptic Validation Technician:

Sep 2010 - Dec 2010

. Routine and Non-routine sampling of viable air and

non-viable particulates in all grade areas like A, B,

C and D with appropriate gowning required as per

different grade areas.

. Performed Water testing, sterility testing, Bioburden

and endotoxin testing.

. Took swab and rinse samples for cleaning validation

study and submitted them for the analytical testing.

. Helped supervisor in executing validation protocol

and generating validation reports.

. Surface plating of different sites in production

areas weekly and monthly by RODAC plates.

. Monitoring of Pressure, Temperature and Humidity in

all work areas like grade A, B, C and D and take any

corrective actions if required.

. Performed filling of vials and bottles in the Aseptic

class 100 areas with proper aseptic gowning.

. Performed Routine Intervention and Aseptic

Manipulation as needed and record in the BPR.

Stevens Institute of Technology,

Hoboken, NJ

Research Assistant:

May 2010 - Sep 2010

. Development of cGMP compliant facility to perform

tests using TOC Analyzer.

. Prepared Quality policy, training policy and required

SOPs.

. Presented a poster on "Implementing Total Organic

Carbon analysis for cleaning validation".

. Assisted in development of Clean-In-Place system for

simulated pharmaceutical products.

Stevens Institute of Technology,

Hoboken, NJ

Quality Assurance Associate

Aug 2009 - Dec 2009

. Reported to the VP of the project on Quality issues,

trends, loses and continuous improvement.

. Assisted in problem identification and processing of

Corrective and Preventive Action (CAPA) reports,

change control and certificate analysis of Analysis

of materials.

. Quality Assurance testing on incoming raw materials,

packaging components, and finished products.

. Audited pharmaceutical documents like Batch records,

protocols and SOPs for GMP compliance.

. Checked all the lab repots, validation reports and

quality of cleaning of the working areas for GMP

compliance.

RPG Life Science Limited,

Gujarat, India

QC Chemist:

Nov 2007 - July 2008

. Performed QC testing of raw materials, in-process

materials and finished products using HPLC (Shimadzu,

Agilent), GC, pH Meter, UV-VIS Spectrophotometer,

Dissolution, Disintegration, Friability, Hardness of

Tablets, TLC and Colorimeter by following SOPs and

GLP regulations.

. Performed Loss on Drying, Absorbance, Optical

Rotation testing and TOC assays on routine samples.

. Documented, interpreted and reported test results

within the scheduled time interval.

. Released sample analysis results and other necessary

test data in timely manner.

. Notified department supervisor/manager regarding

omissions, incomplete testing results or other

irregularities and assisted in investigations of OOS

results.

. Worked within the laboratory in a team environment,

assisted with QC initiatives, actively participated

in QC projects and team meetings.

. Maintained the cGMP guidelines as per MHRA (Medical

and Health products Regulatory Agency).

ACADEMIC

PROJECTS:

. Implementing Total Organic Carbon for Cleaning

Validation

. Determination of Analgesic & Anti-inflammatory

activity of holostemma annulare by using HPLC.

. Validation protocol for maintenance, repair and

verification activities of packaging line equipments.

. Bio Pharmaceutical Facility for making sterile

protein products using cell culture technology.

. Comparison of Quality system regulation of medical

device between USA and Japan.

. Comparison of Protein free culture media and serum

media.

PROFESSIONAL

AFFILIATION:

. Certification of Validation and Regulatory Affairs.

. Member of International Society of Pharmaceutical

Engineering (ISPE).

. Vice President of Student Union 200-2007.

. Member of Indian Pharmaceutical Congress (IPC).

. Active volunteer in BAPS, a socio-spiritual

organization and a NGO affiliated to United Nations.

REFERENCES: Available Upon Request

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