Mostafa Ahmed khairy

Dear Sir /madam

I am a professional pharmacist, has more than 17 years’ of experience, at a leading pharmaceutical companies, in the field of R&D, quality and regulatory requirements 

Experienced on different dosage forms; solids, DPIs, semisolid, liquid and sterile products (injections, ophthalmic and inhalations).

Experienced with the most of guide line SFADA, ICH, EMEA and FDA 

I understand the commercial, business and regulatory compliance challenges faced by the organizations. 

I have a strong management and leadership style,

Enthusiastic, creative and Team worker. 

Now I am leading a team of 22 member

I Have a Total quality management diploma and Six SIGMA Green belt

Sincerely

Mostafa Ahmed

• Global Napi :  From 1st of July 2009 till now
  • I working as R&D Manager at Global Napi Pharmaceuticals from first of July 2015 until now.
  • I Worked as R&D Section Head at Global Napi Pharmaceutical from first of July 2009 until july2015.

job description 

• Manage formulation and development of new products (solids, DPIs, semisolids, sterile (injections, inhalations and ophthalmic preparations)).
• Manage research and development to meet organization needs.
• Manage development and implementation of procedures and technique using QBD and Risk assessment technique.
• Manage technology transfer from R&D to production departments 
• Manage Development and Design of stability indicating Method by different analytical technique for separation and analysis of new product, new chemical entities, and impurities.
• Manage validation of stability indicating method of analysis.
• Dissolve any trouble shooting with respect to production process.
• Dissolve any trouble shooting with respect to any analytical problems.
• Responsible for all reports and required documentation for regulatory requirements.
• Manage and coordinate working plan with other departments.
• Manage in vitro studies and documents for these studies.
• Manage introduction of registration and development products into the stability program.
• Manage analytical method transfer from R&D to QC.
• Experienced on the following analytical sets 
•          UPLC: waters, HPLC (waters, shimadzu and Agilent), GC:  Shimadzu and Agilent, Atomic spectorophometry PerkinElmer, UV PerkinElmer and shimadzu, ICP PerkinElmer, potentiometry, Dissolution tester (Hansson, Pharma test and erweka) 
• -Review all procedures, specifications, monographs and calibration S.O.P.
• -On-job training for person under my responsibilities.
• Estimate Department budget for approval from top management and conduct work according this budget limit. 
• Perform Annual appraisal for persons under my responsibility 

• Medizen :From February 2008 till June 2009
  • I worked as R&D unit Head at Medizen Egypt pharmaceutical industries.

• SIGMA :From October-2005 until February -2008 
  • I worked as Senior Methodology and stability at SIGMA pharmaceutical industries from October-2007 until January 2008.
  • I worked as quality control analyst at SIGMA pharmaceutical industries from October-2005 until October-2007.

-Certified green belt Six Sigma 2020.

-Diploma, applied total quality management from business excellence centre in  collaboration with institute of leadership and management ilm-UK.

                 From october-2012    to   March -2014

          Courses:     1-Project management

                             2-Statistical quality control

                             3-Orange Six Sigma

                             4-ISO 9001, 14001 and internal auditing

                             5- Quality planning.

                             6- Quality function

-B.SC of Pharmacy, May 2005, Tanta University   Grade: good.