Project Manager Quality Control

Quality Objectives:

* Quality Control: Strong ability to perform quality control with good

knowledge of cGMP, GLP, GCP & QSR, CAPA & ICH guidelines.

Straightforward with the co-workers, good leadership on the field

with well experience.

* Quality Assurance: Highly knowledgeable in DoE (Design of

Experiment), data interpretation and FMEA. Good in testing of raw

material, In-line process material and final packaging product. Good

skill in perform the quality testing, maintaining the both paper &

electronic record.

* Validation & Regulation: Academic concentration on Validation &

regulation for pharmaceuticals, Strong knowledge of P&ID, IQ, OQ, PQ,

VMP, SOP. Ability to perform in NDA, INDA & ANDA application.

Members:

* ISPE: Active student member of International Society of

Pharmaceutical Engineering.

* RAPS: Active student member of Regulatory Affairs Profession Society.

Education:

* Stevens Institute of Technology: [ Master in Science] [GPA: 3.66]

> Major: Pharmaceutical Manufacturing.

> Concentration: Validation, Quality & Regulation.

* N.G.S.M. Institute of Pharmaceutical Sciences. [B. pharmacy] [GPA:

3.7]

> Major: Pharmacy.

Technical Skills:

* Minitab 16

> For DoE (Design of Experiment), Control Chart, Process

Capability, Pareto Chart, Interpretation of Data.

* M-Files

> For Storage of Data, Electronic records and maintenance and for

updating version.

* Microsoft Word, Excel, Power-point

Projects:

* Quality Engineer: (For HBD Project)

> Prepared Quality manual, Quality Policy of project

> Review and approved document that meets our Quality Policy.

> Followed 21CFR 210, 211 for our products

> Preparation of CU spreadsheet

> Preparation of Quality Audit manual

Paper Presentation:

* Design of Sterile Pharmaceutical Manufacturing for Injectable Liquid:

Prepared detailed design of sterile pharmaceutical manufacturing for

injectable liquid, prepared in & out of material flow, personal flow

and waste flow. Develop protocol for each flow. Design Class-100,

10000 & 10000 for each room with the water flow. Also, concentrate on

different types of door to maintain the sterility area.

* Validation of Equipment:

Develop IQ, OQ & PQ Procedure for validation. Follow the SOP &

protocol to obtain data of IQ, OQ & PQ. Use Equipment with water and

then actual material to obtain data.

* Regulation and Compliance of Oncology drug in all countries: Obtain

Regulation & Compliance of Oncology drug, different procedure for

approval of Oncology drug. Comparison of FDA regulation with other

country regulation for Oncology drugs like Canada, Australia, Europe,

Japan & India. Positive & Negative points on each regulation.

* Project management of establishment of sterile facility for

outsourcing:

In a role of Project manager, have responsibility of organization of

workers and In a time limit, development of facility to give full

patent benefit to the company.

Industrial Experience:

* Micron Pharmaceutical Ltd:

> Intern in Quality Control Department.

December 1, 2008 - June 30, 2009

Strong work experience in quality control department to maintain

the quality, purity & efficacy of the product. Good knowledge and

ready to solve the ongoing process quality problem.

Responsibility: To perform quality test of raw material, In-

process material and the final pack material. To check, evaluate the

area of problem in the process. To submit the report of quality tests

& any problems on the ongoing processes

* Micron Pharmaceutical Ltd:

> Assistant in Manufacturing Department.

February 1, 2007- August 31, 2008

Excellent knowledge of the manufacturing processes. Have a great

experience in the oral solid, liquid and semisolid process. Have an

experience in the Injectable liquid preparation too.

Responsibility: To check the manufacturing process and report.

To follow SOPs for manufacturing processes. Work on fluidized bed

dryer, ball mill, filling, inspection and packaging machine.

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