Quality Auditor-Freelance
TFS, United States

TFS is a Global CRO headquartered in Sweden. We genuinely believe that "Global in mind and local at heart" is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate.

• Prepare, conduct and follow up on all types of internal and external GxP audits including system, process, investigator site and pre and post-marketing pharmacovigilance (PV)
• Support and guide operational staff in preparing investigator sites for regulatory inspections
• Support, guide and facilitate regulatory inspections and customer audits of the company and/or projects
• Peer review of audit reports
• Provide quality management advice and support to internal and external clients

Requirements

• In depth knowledge of GxP regulations and guidance
• Previous pharmacovigilance auditing experience is required, with thorough knowledge of requirements for PV compliance
• Knowledge on GxP regulated computerized system validation activities and principles
• Three to five years’ experience of auditing in two to three GxP areas
• Travel to audit sites

Benefits

A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients

Job Rewards and Benefits