Tracy Saunders is a freelance QA consultant with over 25 years’ experience in the pharmaceutical industry, working to GCP, GCLP, GMP and GDP standards. She has worked in a wide variety of therapeutic areas from Phases I to IV (including oncology, infectious diseases and cardiology), across pharmaceutical, medical device, biotech and CROs, conducting audits and other quality support services in all the GXPs listed above.
Tracy provides services across UK and Europe, as well as remotely for a number of clients further afield, such as the US. She can work with clients on a long-term support basis, for a series of audits, or for individual projects, and is very flexible to client requirements with a pragmatic approach to quality in general.
Having graduated in Maths and Chemistry, Tracy started her QA career in a Data Management/ Statistics CRO, before moving into GMP/GCP/GCLP roles and has been involved in preparing for and hosting regulatory inspections in GCP and GMP. She held various Senior Management roles over 10 years before setting up as a freelance QA consultant in 2013.

Availability for Work

Remote, United Kingdom, Europe

Areas of Expertise

Auditing, Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Good Manufacturing Practice (GMP), Information Technology (IT), Medical Devices, Quality Management Systems (QMS), Standard Operating Procedures (SOPs), Inspection Preparation, Good Distribution Practice (GDP)

Contact Details

52 Orient Place
Canterbury
Kent
CT2 8AW
England

Tel: +44 (0) 7976 641596

Email address: tracyasaunders71@gmail.com

 

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