
Sahar Makram Elnanai
quality assurance
Smouha, Alexandria, EgyptWork Experience
Quality assurance directorFull Time
Education
Bachelor's Degree in Pharmaceutical
King saud universityJan 1988
Achievements
1. Multinational Contractors GMP compliance and business needs management: • Ability to appropriately balance compliance and business needs to ensure problems are identified, clearly articulated and resolved with the right sensitivity to timing, risk consideration and overall business impact for GSK, Sandoz and Novartis as Pharco B contractors. 2. Excellent influencing and negotiation skills to achieve win-win situations Demonstrated through the continuity of business contracts with Sandoz, GSK and Novartis over 9 + years. 3. Strong organizational skills demonstrated through: • Directing two Quality assurance departments of 46 employees that manage compliance with Quality requirements in 1200 employees’ company. 4. Validation team leader (Expert) August 2008 to Present (10 + years) 5. Ability to propose innovative solutions by thinking creatively and bringing forward common-sense solutions demonstrated through :
Skills
- Sterile manufacturing
- quality management
- Validation
- Process Validation
- Cleaning validation
- Qualification
- Risk Management
- Change Control
- Deviation
- CAPA FOLLOW UP
Languages
English
Fluent