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Experience

FRQA. Experienced Director Of Quality Assurance with a demonstrated history of working in the biotechnology industry. Strong quality assurance professional skilled in all areas of global clinical research. 

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Heather Wells has worked with

Immunocore
Circassia Ltd
Takeda Pharmaceuticals
Quanticate
Staticon Int
FOCUS
Bayer plc

Completing various roles and assignments in the areas of Data Management, Statistics and Computer Systems Validation. Perform audit, training and hands-on help. Including:

  • Various auditing contracts mainly on CSV, Data Management and Statistical Services
  • Sales and Marketing Audits (13 during 2006 and 2007) for one company. For cause Sales and Marketing audit for the same company in 2009.
  • Hosting MHRA Inspections
  • Assisted with the validation and implementation of a system to manage SOPs and Work Instructions
  • QA Manager for a small CRO, preparing for ISO accreditation which was successfully achieved on the first attempt
  • Performing ISO 9000:2000 internal audits for many departments.
  • Writing UAT scripts for a Remote Data Entry System (Oracle Clinical)
  • Validation Consultant on a medium-sized in-house development of a Statistical Analysis System (from requirements to production release of V1.0) – with responsibility for the document management of all the validation documentation (both paper and electronic)
  • Writing UAT scripts for a complex distributed data entry system and preparation of the reports
  • Various small training contracts