GCP Auditor Resume
Clinical trails are essential to improve the quality of human lives. However, lots of risks are involved in finding whether one particular medicine or newly-invented treatment can work on patients or not. Hence, an international body lays out procedures following which the ruling government can use the idea and set regulations for clinical trails on human subjects. To follow those regulations pharmaceutical companies and medical research centers hire GCP (Good Clinical Practice) auditors. These auditors can help medical organizations in complying with GCP standards for clinical trails.
A GCP auditor has to be a bachelor in science. He/she must hold auditing experience of a pharmaceutical industry and must have comprehensive knowledge of GCP regulations.
GCP Auditor Resume Example
David T. Hurtado
4102 Emily Renzelli Boulevard
Hollister, CA 95023
Phone: 831-630-2859
Email: dthurtado@anymail.com
Career Objective:
To work as a GCP auditor for “Sterling Pharma,” and perform audits on internal systems and modify standard operating procedures to enhance clinical trials.
Summary of Skills:
- Excellent work experience of pharma industry
- Complete knowledge of GCP standards and regulations
- Strong observational, analytical, and organizational skills
- Excellent experience in auditing and investigating vendor audits
- Excellent teamwork skills and ability to work independently
- Flexible to travel within and outside the country
Work Experience:
GCP Auditor
PQR Pharmaceuticals, Hollister, CA
November 2013 - Present
- Organizing and performing audits on internal system as well as investigation on vendor audits
- Developing and implementing new standard operation procedures
- Creating test materials and guidelines for clinical tests
- Reviewing and revising legal contracts and quality agreements with vendors
- Planning, scheduling, and conducting audit programs
- Performing quality assurance on clinical and non-clinical documentation
GCP Auditor
ABC Pharma, Hollister, CA
February 2012 - October 2013
- Interpreted drug manufacturing procedures and applied GCP standards
- Maintained audits files and operating process logs
- Reviewed and resolved compliance issues and ensured quality
- Examined and modified documentation systems for easy uploading and access
- Prepared and implemented audit plans and performed quality inspection
- Attended state and federal training programs and trained staff
Education:
-
Bachelor's Degree in Science
Hollister University, Hollister, CA
2011
Reference:
On request.
