ABOUT QA INSIGHT
Delivering uncompromising quality assurance and compliance expertise to the Medical Device and Pharmaceutical sectors worldwide.
About
QA INSIGHT Ltd. is owned and managed by Rita Gabay. With clinical background, and M.Sc. in Quality Assurance and Reliability, Rita has over 20 years of experience in pharmaceutical, medical devices and in-vitro diagnostic industry: marketing, Clinical Quality Assurance (phase II to IV), and management of Quality Systems compliant with ISO 9001:2015 and 13485:2016.
Rita served as Quality Assurance Manager in International and Local pharmaceutical, medical devices and in-vitro diagnostic companies.
During her work Rita set up, implemented and maintained ISO (9001 and 13485) as well as GCP compliant Quality Systems; and performed vast range of 1st and 2nd party audits and Clinical Trials Audits (GCP and ISO 14155).
- Clinical Quality Assurance (phase II to IV)
- ISO 9001:2015 and ISO 13485:2016 Quality Systems
- GCP and ISO 14155 Clinical Trials Audits
- Professional QA Training and regulatory consulting
Philosophy
QA INSIGHT is fully committed to the client with professionalism as a fundamental business principle. The core of the process is achieving customer satisfaction by employing knowledge and experience. Our philosophy is simple: to offer excellence, integrity and reliability of performance in a straightforward, client-focused way.
Vision
To create and maintain partnerships with customers; to provide client-oriented service at professional expert level applying high ethical standards; to ensure that our efforts are a profitable experience to our clients; to be recognized by client as a trusted partner.
Values
Values – We believe that integrity and trust, experience and expertise, customer-oriented flexibility and truly personal service are the keys for success. We practice these values on every job.
Our motto is: The secret of success is constancy of purpose. Benjamin Disraeli.
Why to choose our services
QA INSIGHT Ltd. brings together skilled and experienced professionals with proven expertise in QA management and auditing in GCP, ISO 14155, ISO 9001 and 13485 areas.
With many years of experience covering Quality Systems management and auditing in clinical research departments and manufacturing facilities QA INSIGHT possesses all skills and capacities needed to provide independent, practical, professional and high-quality solutions for clients seeking for out-sourcing of auditing and QA consulting activities, all timely and at a very reasonable and competitive rate.
Experience & clients
Rita lectures at the professional and educational forums on GCP, ISO and Medical Devices regulations.
Rita is a certified auditor. She holds Certificate of International Register of Certified Auditors, and Medical Device Single Audit Program (MDSAP).
Among our clients are German Notified Body - mdc - Medical Devices Certification GmbH, well-known worldwide CROs, as PAREXEL and Quintiles, and pharmaceutical companies - Gilead, J&J, Daiichi Sankyo and many others.