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Mai CV

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Mai CV

  1. 1. Mai Ahmad Taha Tolba ZaKi El SiSi St. From Talateni St. –Fesal, Egypt. Mobile:(+202) 01009704129 E-mail : maiahmad_83@hotmail.com OBJECTIVE :- Seeking a challenging position within your company, which is dynamic, progressive and growth oriented to enhance my skills and attain experience. PERSONAL DATA :- EDUCATION :- - BSC Pharmaceutical Science, Faculty of Pharmacy (Cairo -University ) . Very Good Degree with Grade of Honor Graduation Date : May 2005 - Secondary School :Huda Sharawy experimental language school. SKILLS :- Language skills :- - Fluent in both spoken and written Arabic. - Fluent command of both written and spoken English Computer skills :- - Microsoft Office (Windows, Word, Excel) - Network (Basic Network Skills). Personal skills :- - Presentation Skills and working in teams. - Problem Solving and Decision Making. - Report Writing. - Ability to work under pressure. - Self-motivated, ambitious, dependable, hard worker well organized. - Ability to learn new tasks quickly. - Treatment with person's regardless ages & levels. - Treatment Fairly with workers & deal with hard situations. - Date of Birth : 24/03/1983 - Place of Birth : Cairo - Nationality : Egyptian - Marital Status : Married
  2. 2. Mai Ahmad Taha Tolba ZaKi El SiSi St. From Talateni St. –Fesal, Egypt. Mobile:(+202) 01009704129 E-mail : maiahmad_83@hotmail.com -Treatment mistakes & facing risks with high efficiently & effectively. TRAINING :- - Training in pfizer Egypt as a medical representative (July 2004). - Training in Dr./ Doha pharmacy (from July 2005 till September 2005). - Traning session on local actions following recall request from authorities. (Held by the Quality Officer of Hospira – Middle East) (May 2015) - Training sessions on applying the CTD. COURSES :- - Shape your future course (Egyptian pharmacy syndicate July 2005). - Communication skills (Egyptian pharmacy syndicate Jan 2010). - Certificate of ICDL Held April 2010 Work Experience :- Regulatory affairs Manager in UGP Pharma (Outsourcing agent for Pfizer) handling the following: (June 2013 up till now) **Supervise the registeration process & manage all the difficulties that may happens in the ministry of health **Supervise all technical procedures of Imported drug Registration for Hospira; a very well reputable American generic company for Hospitalization required medicines and drug devices. **Coordination between Hospira and UGP for all regulatory related issues. **Supervise the Preparation and admission of the company products' registration/re- registration - pricing – variation – analysis and stability files to the national regularity authority. **Communication and follow up with the regulatory authorities (Central Administration of Pharmaceutical Affairs, National Organization for Drug Control and Research,National Organization for Research and Control of Biologicals, and Ministry of Health) for any problems facing the registration process. **Supervise the renewal process and variation of company licensing.
  3. 3. Mai Ahmad Taha Tolba ZaKi El SiSi St. From Talateni St. –Fesal, Egypt. Mobile:(+202) 01009704129 E-mail : maiahmad_83@hotmail.com Regulatory affairs specialist in the central administration of pharmaceutical affairs in the Egyptian MOH (Ministry of Health) handling the following: (February 2009 to May 2013) 1- Technical committee including new registration, renewal & variation studies 2- Companies issue requests, company name change. 3-Change control. • VACSERA-BIOTECH.(Building#2) (Quality Assurance Dept.) (June 2006 to January 2009) N.B:- Building#2 is concerned with the production of :- 1-Insulin (Mix, N, Regular) under license of Bioton (POLAND) 2-Mencevax A,C under license of GSK(BELGIUM) 3-Multidose diluents under license of GSK (BELGIUM) Quality assurance specialist responsible for :- 1- Daily audits on the production activities with applying GMP rules within the production shifts. 2-Tracing and investigation of any deviation occur during production process. 3- Reviewing the batch production records. 4- Internal audits for different departments according to the annual plan. 5-Receiving of bulk crystals of insulin from different companies (Bioton, Biocon , Dongbao,Wukhart) 6-Periodical annual review of SOPs of Q.A. and participate in review of SOPs. 7-Writing , approval and updating of all SOP related to the quality assurance , ensuring implementation of all other SOPs. 8-Issuing of NCRs in case of non compliance with GMP regulations then follow up and approve the related corrective and preventive actions.
  4. 4. Mai Ahmad Taha Tolba ZaKi El SiSi St. From Talateni St. –Fesal, Egypt. Mobile:(+202) 01009704129 E-mail : maiahmad_83@hotmail.com 9-Approval of the artworks of the secondary packaging materials (labels,leaflets,single boxes, group boxes, shipping cartons) according to the given specifications .

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