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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.

Please get in contact

Available for:

Audits

Investigator site, vendors, internal systems

Training and mentoring

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

Inspection readiness

Specialising in MHRA, also FDA and Health Canada.

Quality systems

Implementation and improvement of quality systems