Description
This position is responsible for leading the GCP Quality Assurance Audits to assure that all aspects are executed in compliance with applicable US FDA, ICH GCP Guidelines and other government and/or country specific regulations. This is an exciting mid sized Pharmaceutical company that is thriving and aggresively looking to expand.Job Requirements:
-Investigate internal GCP Quality issues, initiate process improvements and promote standardization of best practices.
-Assure the integrity and quality of clinical data by independently manage, lead, participate, and follow-up on routine and directed; internal and external; domestic and international GCP audits. Audits will include, but are not limited to: internal systems, investigator study sites, vendors, and study reports.
- Act as a subject matter expert by providing GCP Compliance advice to Clinical Operations and Clinical Development, including updates for applicable regulations.
-Supports the administration of the company's training program, and conduct Good clinical Practice training.
Qualifications:
-5+ years of related experience in the Pharmaceutical/Biotech industry
-Strong knowledge of Code of Federal Regulations and ICH Guidelines governing clinical trials and recent initiatives.
-Excellent verbal and written communication skills and ability to work well in teams
This is an urgent role with open interview slots available asap for the right candidate. Please
To find out more about Real please visit www.realstaffing.com