MMC Quality Assurance Auditor
Medical Consulting Dr. Schlichtiger GmbH has been operating in the European area for more than 20 years.
In January 2010, we became a member of the Medpace Group and will shortly operate under the name of Medpace
Medical Consulting GmbH. As a result of this integration, we have been able to extend our project scope into
global markets.
Location: Germany
Position Type: Full-time
Job Duties:
- Conduct internal system audits as well as study-related audits (Phase I-IV) in regards to
compliance with Standard Operation Procedures (SOPs), Good Clinical Practice (GCP), and
applicable laws and regulations;
- Assess compliance of investigators and vendors and review study documents;
- Host inspections and sponsor audits and function as contact person for all third party auditors;
- Establish and maintain audit programs;
- Monitor the implementation of corrective and preventative actions;
- Work with internal departments regarding quality issues;
- Conduct fraud and for cause investigations with the department head; and
- Write SOPs and manage the SOP system.
Qualifications:
- Bachelor's degree;
- 2 years experience in QA or clinical development (e.g., as a CRA) in the pharmaceutical industry
or in a CRO;
- Past audit experience;
- Fluency in written and spoken English, additional languages would be helpful;
- Excellent, proven interpersonal and communication skills;
- Sound knowledge of German and European GCP regulations; and
- A high degree of initiative and excellent organizational skills.
Travel: Average of 50%
To apply for this position, send your resume to: r.abert@medpace.com
Print
Send Link by E-mail