Rana Golzar Eng.,
Personal Vision and Mission Statement
I will do my best In order to triumph for St. George! CSV in my country! Struggle to fill the current gap of CSV
in IRAN, with being pioneer in this path.
Superior experience in lot of engineering aspects of pharmaceutical companies, highly team working spirit,
endeavor, pragmatism and confidence will exist as a leader on any moment during this journey.
The most delightful part of my life is gaining the goals which were only a dream!
Education: University B.Eng. / Certified ECA
Working Experience: 20 Years, Related Place of Birth: Iran/ Tabriz
Languages: Persian/Turkish/English/ Nationality: Iranian
Certified ECA, European Compliance Academy, Computer Validation Manager, Heidelberg, Germany (2009-2011)
University Esfahan Azad University B.Eng. Computer in Software, Esfahan, Iran (1991-1995)
- VM Machines (Virtual Machines infrastructure)
- TCP/IP & Internet Transmission Protocols
Qualification & Certificates
- Professional Web Designer Qualified Person, 1999, Iran
- YOKOGAWA, Automation monitoring & controlling system, Training course & Certification, 2001, China
- CITECT, Automation monitoring & controlling system, Conference & Certification,
- 2002, Iran
- Calibration Certified Person, Training Courses and certifications, 2006-2008, Iran
- Technical Certified Person in maintenance planning, PM & EM, 2007-2009 Iran
- FMEA Qualified (Failure Mode & Effects Analysis) : 2009 , Iran
- EFQM Qualified: 2009, Iran
- Validation courses in Basic : 2009, Iran
- Computer Validation, GAMP5 Approach , 2010, Spain
- Computer Validation, 2010 ,Spain
- Computer Validation, Risk Management, 2011 ,Germany
- Computer Validation, Maintaining the Validation State, Sep.2011, Germany
- Computer Validation Conference , The New Annex 11, May 2012, Denmark
- Computer Validation, GAMP5 & 21 CFR Part11 compliance with CSV, April 2017,INDIA
Company name: Pazhoheshyar Web Designing Group, Tabriz- Iran
Duration: Part time, 1996, 6 years
Position: Web Designing Dept. (Graphic, Animation, Programming)
Company name: (Daana) Zakaria Tabriz Pharmaceutical Co., Tabriz, Iran
Duration: Full time , 1997 , 14 years
- Position: Computer Dept. Manager
Comment: Giving full service In IT department such as IT infrastructure designing, Network topology designing, Training, Backup management, SOP writing, System Analyze, Software supporting, Hardware maintenances, Network supporting, Internet supporting , Problem and Change management, Security management, Support/Help desk back- end & front- end .
- Position: Technical Planning Dept. Manager
(Commissioning of this departments)
- Duration: 7 Years
- Calibration Laboratory
- Design and establishing of Calibration laboratory based on
- 1725 STANDARS, Calibration software developing, preparing
- of calibration devices and reference, calibration of instruments, label preparing and periodic inspection, periodic and random calibration, preparing of C.B.U instruments for urgent time, issue the calibration certificate and calculate of deviation for showing the accuracy and useful class of instruments, SOP's writing.
- Industrial Computers Management
- Management of Automation system controlling and monitoring in all production lines (such as autoclaves, washing and sterile machines), laboratory's equipment, nitrogen lines, waste water system controlling, water treatment line.
- Head of Machinery Maintenance Planning, PM, EM Team
- Technical archiving system, PM software developing, maintenance services describing, controlling and random audit of maintenance, PM SOP's writing, FMEA calculating.
- Responsible person in Validation group as a representation of Technical department, validation of autoclaves, validation of ovens, writing technical reports of validation.
Bold Projects in Danna Pharmaceutical
- Y2K Problem solving in 2 IMA vial injection line (2000 problem of date) Factorylink controlling system) Washing & Sterile Machines
- Nitrogen production line automation designing with Kaifeng Chines group
- Water treatment automation line problem solving
- Design and establishing of calibration laboratory based on 17025
Company name: Behestan Tolid Pharmaceutival Co., Tehran, Iran
Duration: 9 Months, 2012
Position: ICT Manager
Comment: Full service of IT, Renewing of Network Infrastructure, Software and
Planning of Computer Validation
Company name: Pharchem Tech Co.(PCTC) , Tehran,Iran
Duration: 2012- 2013
Position: CSV Manager
- As a leader of the CSV team, training of the team, audits of the client pharmaceutical factories, planning of several CSV projects, project developing, training courses or seminars done by me.
- Preparing CSV master plans and suggesting the best practices to be implemented based on GAMP5 approach and PIC/S standards.
- Software Verification (professional verification strategies of software)
- CSV, Computer System Validation, in all aspects.
- Conducting Several CSV seminars in pharmaceutical companies,( Zahravi Pharma Co., Daroupakhsh Group, Sobhan Oncology Pharmaceutical, Exir Pharma Co., Behestan Tolid Co.,Pouyesh Darou, Tofigh Darou, Pars Isotoup Pharma …)
Company name: Darou Darman Pasargad, Tehran, Iran
Position: IT Manager, M.D Technical & CSV consultant
Comment: Network Infrastructure support and maintenance, Software and Hardware supporting, CSV based infrastructure designing
Company name: Vitane Pharmed Co., Tehran, Iran
Position: Managing Director Consultant, in Technical & CSV
Duration: 2012- present
Comment: Technical Supporting, QA & GAMP 5 approach consulting, CSV based infrastructure designing in IT and automated systems like BMS
Company name: CELL TECH Pharmed Co., Tehran, Iran
Position: CSV consultant
All Aspects in Validation & CSV
Duration: 2015- Present
Company name: Pharma Green System Co., Tehran, Iran (Self Company)
First & Unique Company in CSV (Computerized System Validation) In Iran
Validation based Company, (all aspect of Validation & professional in CSV)
Position: Managing Director
Duration: 2015- present
Comment: Validation CSV Professional Projects, consulting, designing, training, audit, implementation and development in Technical, Automated systems and all Gamp 5’ approach process.
Activities in Iran:
- First CSV conference in Iran , subject in: Computerized System Validation with GAMP5 approach ,June 2014 ,Olympic Hotel Tehran
- Iran FDO (Food and drug organization in Iran ), 1 day training of CSV
Some Bold Pharmaceuticals which I was related with them in various part of CSV and VALIDATION
- SOBHAN ONCOLOGY
- ARIOGEN Pharmaceutical
- Behestan Tolid Pharma
- Exir Pharmaceutical
- Vitane Pharmed affiliated to German Vitanepharma
- Cell Tech Pharmaceutical
- Part Darou Alvand , Sister company for Computerized System Validation in Machinery and clean rooms
- Aborihan Pharmaceutical , all part of Validation , cooperating with Pharchem Co.
- PARS Isotope Pharmaceutical related to Iran nuclear organization
This resume has been achieved by enthusiasm working in pharmaceutical industry after 19 years.
It is part of my life and so valorous for me.
Thanks for sharing your time with my experience.