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I previously worked with AstraZeneca for almost 22 years, having joined ICI Pharmaceuticals as a Quality Assurance Officer in 1985. Through the demerger and formation of Zeneca in 1993 and the merger with Astra in 1999, I worked in a number of different jobs at the Macclesfield UK Operations site until July 2007.
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In my last 4 years at AstraZeneca, I was Quality Systems Manager for a new group created to oversee the internal and external audit and inspection activities for the site. Most recently I managed the implementation of a risk based, electronic deviation management system, including the associated training for over 300 personnel. Alongside those tasks, I supported international projects to improve sterile manufacturing capabilities in India and FDA PAI preparation activities, in France.
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Before that, I managed the Quality Assurance group supporting a new aseptic production plant. Alongside this, I facilitated a quality improvement team within Sweden Operations, to resolve FDA inspection observations. I also had a quality liaison role with Japan. 1997 – 2003.
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Prior to that, I managed the microbiology laboratory group of Quality Asssurance, with a remit to resolve issues with false positive sterility tests and FDA inspection readiness. To achieve this, I managed a £1m construction project to resolve laboratory layout and test equipment problems, as well as a complete overhaul of the processes for recording raw data. The latter included creation of the Microbiological Reporting System, an electronic tool for capturing and reporting microbiological monitoring data. 1991 – 1996.
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Between 1987 and 1990, I managed the production team and plant responsible for generating the launch and early sales stock of a sterile implant in a pre-filled syringe. During 1991 I acted as internal aseptic manufacturing consultant, to the project team building a sterile powder filling facility at Newark, in the United States. Over this period I was based in the US.
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