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QED-QED Principal Consultant Profiles

     

Alan Smith   CChem, MRSC PG(Dip)IPS

A Chartered Chemist and Qualified Person with extensive quality and business experience within the pharmaceutical industry. Alan gained Qualified Person status in 1994 and has a Post Graduate Diploma in Industrial Pharmaceutical studies. He is a member of the Pharmaceutical Quality Group.

Alan has worked for major pharmaceutical companies for over 20 years and has direct experience of API and Drug Product operations, QC and Microbiology laboratories and Quality Assurance activities, covering most major pharmaceutical forms (supplied to all major markets, including the U.S. and Japan).

Alan has specialist knowledge in the manufacture of cytotoxic products and has successfully led the QA activities for a new cytotoxic solid dose facility. He has significant management experience and has managed large teams through periods of high uncertainty, including a plant closure. Alan is a change agent and has been pivotal in implementing new ways of working, utilising developed change management and lean manufacturing techniques to give rapid business benefits. He has also successfully managed product transfer projects across companies and into the Third World.

      

Alice Li    CChem, MRSC, DMS, MRQA

A Chartered Chemist with Post Graduate Management Diploma and an established member of British Association of Research Quality Assurance and Pharmaceutical Quality Group.

In her career to date, Alice has worked for companies such as The Wellcome Foundation, Serono, Upjohn, Pharmacia & Upjohn, Vanguard Medica, Vernalis and Aventis. She was also a consultant Industry Pharmacy Course lecturer for a Technical College. She has comprehensive knowledge, skills and experience in the areas of quality systems, validation, regulatory support, audits & inspections, and training, both within the R&D and commercial operations environment.

 As an independent consultant, Alice has worked with small and large companies on a variety of projects. To date, she has led companies through successful regulatory inspections and PAIs. She has performed numerous third party/suppliers GXP/ISO audits, developed and implemented inspection readiness training programs, quality systems/processes for various companies. She has undertaken successful validation of systems, processes and equipment. Alice has lectured and presented in courses and conferences.

 

 

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