Roshanak Agharafeie

Applying for

Cell phone: +98-912-******* Address : unit 5, No. 58, Eastern

Email: abn0o2@r.postjobfree.com Sohrevardi Ave., Mehrvila, Karaj, Iran

Qualifications

• More than 5 years of experience as a validation professional in biopharmaceutical field

(Pasture Institute of Iran)

• Skilled in validation documentation, sop and protocols for validation activities

• Professional in media fill and process validation

• Expert in IQ, OQ and PQ especially for autoclave, oven and fermentor

• Having experience in clean room qualification and particle counting

• Outgoing, responsible, self-motivated, with good communication skills

• Working independently as well as in a team

Professional Work Experience

Validation Professional 8.2007-present

Pasture Institute of Iran, Karaj, Iran

Pasture of Iran is a branch of Pasture institute of Paris, operating for over 50 years in a wide

range of pharmaceutical products and over 5 years biological vaccines and products.

Responsibilities:

• As a validation expert (validation team) responsible in the following activities: (2007- present)

Preparation of different process validation protocols (fermentation, purification, filling and

formulation, cleaning, media fill, clean room, IQ&OQ&PQ for instruments, sterilization and

Depyrogenation process, etc)

Preparation of validation sops (how to work with biological and chemical indicators and data

logger and particle counter, change control, revalidation, etc)

Preparation of technical reports

Participation in IQ, OQ and PQ of Autoclave, Oven, tunnel, Fermentor, cell disruption,…

Participation in analytical method validation protocols preparation such as biotechnological

applications in petroleum industry and also project manager for biotechnological applications in

petrochemical industry,

Project manager and Researcher in Biotechnology projects 10.2006-8.2007

Iran Technology Analysis Network (ITAN), Tehran, Iran

The network is involved in feasibility study projects for different industries and companies (oil,

gas, petroleum, food, etc)

Responsibilities:

• Project manager: biotechnology applications in petrochemical industry for Research Institute of

Petroleum industry (RIPI).

• Researcher in biotechnology applications in petroleum industry project.

Research and Technical manager 10.2005 -5.2007

Goltash Company, Isfahan, Iran

The company is a Producer of hygienic and cosmetic products and located in Isfahan

Responsibilities:

• Research manager of oral care department

• Technical manager of liquid soap and home care products

• problem solving

Research and Technical manager 8.2002 -4.2004

Rezarad Company, Tehran, Iran

The company is a producer of baby’s Hygienic and toiletry products

Responsibilities:

• Research and Development expert in baby’s product formulation (shampoo & oil &lotion)

• Technical manager of baby shampoo production line.

• problem solving

Manager of chemical laboratory 11.2001-8.2002

Hygienic and Cosmetic Society of Iran, Tehran, Iran

This laboratory is a reference lab for NRC of Iran to control Hygienic and cosmetic product.

Raw materials and final products in this field are checked there.

Responsibilities:

•Managing chemist who checked samples

• checking some samples

• problem solving

Research manager 6.1996-11.2001

Iran Najo Company, Tehran, Iran

This company is a private company which Producers hygienic and cosmetic products.

Responsibilities:

•Managing research and development lab

• design new formulations

• Problem solving

Education

• M.S. in Chemical Engineering- Biotechnology, 2002-2005, Iran

University of Science and Technology (IUST), Tehran, Iran. (www.iust.ac.ir)

• B.S. in applied chemistry, 1991-1995, Sharif University of Technology,

Tehran, Iran. (www.sharif.ir)

Computer Skills

• Professional Software: Familiar with MATLAB

• General Packages: MS office (Word, Excel, Power Point, Outlook), Familiar with AutoCAD

Training

All of the following training was held in Pasture Institute of Iran:

• Training on GMP

• Training on validation

• Training on equipment qualification

• Training on fermentation

• Training on documentation for validation

• Training on cleaning validation

• Training on clean room qualification

There is another course which was held in Ofogh Pharmed Institute:

• Training on process validation

Teaching

General concepts of validation:

I was this teaching course for pasture’s specialists

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