Meet Karen Hunt
I’m Karen Hunt, dedicated to providing you with high quality, fully insured, Independent Quality Assurance services. As the sole founder of ImpactQA Ltd I have nineteen years of experience in the CRO, Pharmaceutical and Biopharmaceutical Industries, to provide high quality auditing and training in compliance with Good Laboratory Practice (GLP) and Good Clinical Practices (Laboratory) standards to local and international industry clientele.
As a full member of both the Research Quality Association(RQA) and the Swiss Professional Association of Quality Assurance(SPAQA), I can confidently assure you that my services are up-to present standards within the industry.
I can offer you flexibility with both long term and short term contracts, where you can benefit from my experience in the successful establishment of GLP facilities, and expertise in gap analysis (in regards to Minimum Quality Standards in Research).
The benefits of working with Impact QA
Services Provided by Impact QA
As an experienced auditor with 19 years in the CRO, Pharma and Biopharmaceutical Industries, I can offer the following services.
- Contributions and Assistance with the set-up of GLP facilities (Bioanalytical, DMPK, and Histopathology)
- Hosting of implementation and routine monitoring inspections by the UK GLP Monitoring Authority for GLP and GCP (Laboratory) compliance.
- Audits of facilities, studies, protocols and reports for compliance with the GLP regulations.
- On behalf of Sponsors, audits of vendors including full-service CRO’s, Contract Archives and Bioanalytical Laboratories.
- Mock Audits in preparation for Regulatory Inspections.
- Contract QA for small GLP Facilities
- Gap analysis in support of Regulatory Submissions for compliance with GCP as applicable to Laboratories.
Member of the following professional QA organisations
Connect with me
For Quality Assurance services, get in touch via Email or connect with me through LinkedIn.
