Heather J Wells MSc BSc (Hons) FRQA

A highly experienced QA professional specialising in GCP (Pharma); both implemented and managed an appropriate supporting QMS (including for ISO 9001); experienced and effective auditor; who has audited around the global; experienced in clinical investigator sites, suppliers and internal systems. Also, experienced in Medical Device clinical investigations, CSV and PV. Gained experience in both CROs and Pharma companies and hosted Regulatory Inspection.

Investigator site, vendors, internal systems

All aspects of audit, Computer Systems Validation and quality systems.

Specialising in MHRA, also FDA and Health Canada.