Magdy Hussein

Experience

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  Alkan Pharma

  May 1999 - May 2002

  Microbiology Laboratory Supervisor

  During this assignment my responsibilities included leading the microbiology laboratory team to support Lilly sterile manufacturing facilities and provide all the QC testing including (Environmental monitoring, sterility testing, sterilization validation, water, clean steam and compressed air systems monitoring ... etc)

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  Pfizer

  May 2002 - May 2003

  Senior Quality Assurance (validation responsible)

  During this assignment my responsibilities included the ownership of the manufacturing site validation program to develop and implement the integrated validation master plan and validation protocols for a multi product site (sterile, dry and liquids) (including: process validation, cleaning validation, equipment and sterilizers qualification, computer systems validation, media fills, HVAC qualification ... etc.

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  Eli Lilly and Company

  May 2003 - Dec 2014

  My responsibilities includes:1. Site leadership team member that develop and monitor the execution of the site long range plan and business plan to make sure the site achieve its mission (including budgeting, capacity, demand management, quality management, safety management, human resources planning, products portfolio, and technical projects portfolio) 2. Lead the the site technical services organization and be a member of Lilly global parenteral manufacturing network to maintain the manufacturing site and products in validated state, continuously monitor and improve the manufacturing processes, define, prioritize and implement the site technical projects3. Site six sigma champion that lead the site six sigma organization to define the site continuous improvement program, prioritize and drive the implementation of the six sigma projects Show less My responsibilities included:1. Site leadership team member that develop and monitor the execution of the site long range plan and business plan2. Lead the multilayer production and packaging organization to execute the business plan and deliver the drug products to the market in time and in full while maintaining the operations in compliance with Lilly global quality standards and HSE standards3. Site six sigma champion that lead the six sigma organization to define the site continuous improvement program, prioritize and drive the implementation of the six sigma projects4. Site sterility assurance steward that lead a cross function team and make the link with global networks to develop and drive the implementation of the site sterility assurance plan including the Oversee the environment monitoring program, sterility assurance deviations and sterility assurance changes and projects Show less - Lead the site quality organization and be a member of Lilly global parenteral quality network to maintain the site compliant with Lilly global quality standards and all applicable regulatory requirements and marketing authorization for local and export markets (including establishing and drive implementation of the site quality systems, oversee the operations at Lilly manufacturing site, 2 contract manufacturers and several suppliers)- Site leadership team member that develop and monitor the execution of the site long range plan and business plan Show less During this assignment I had direct responsibility for on floor monitoring of the production operations and developing and maintaing the site quality systems in compliant with all Lilly global quality standards and regulatory requirements (including: Batch release; Deviation management; Change management; Documentation and data; Annual product review; Personnel qualification and training; Specifications; Stability; Validation practices; Quality auditing and self-assessment; Notification to management; Product complaint and recalls Show less

  • Technical Services Director

    Mar 2011 - Dec 2014

  • Production Director

    Feb 2009 - Mar 2011

  • Quality Director

    May 2005 - Feb 2009

  • Quality Assurance Head

    May 2003 - May 2005
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  Medical Union Pharmaceuticals

  Jan 2015 - Mar 2015

  Technical Services and project Director

  1. Lead the site Start Up team to transfer a manufacturing site physical assets, physical and business processes from Eli Lilly to MUP and develop the site capabilities and systems to manufacture and supply insulin drug products2. Lead the the site technical services organization to maintain the manufacturing site and products in validated state, continuously monitor and improve the manufacturing processes, define, prioritize and implement the site technical projects3. Site leadership team member that develop and monitor the execution of the site long range plan and business plan to make sure the site achieve its mission (including budgeting, capacity, demand management, quality management, safety management, human resources planning, products portfolio, and technical projects portfolio) Show less

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  Novo Nordisk

  May 2015 - now

  Senior project manager who lead project teams to introduce new products to Novo Nordisk Manufacturing sites and global contract manufacturers. Act as the interface between Novo Nordisk research & development and product supply (Manufacturing ) to ensure successfull launch of new Novo Nordisk products. Senior projects manager who leads investment projects and technology transfer projects from Novo Nordisk to CMOs in the international operations (IO) and lead portofolio of operation at the end of the project.

  • Senior projects manager

    Sept 2022 - now

  • Senior Project Manager

    May 2015 - Aug 2022