QA GCP Auditor

UK-London

International Careers

Req #: 11665
Type: Full-Time
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Medpace, Inc.

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				Overview:

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.

Responsibilities:

* Work as a trusted partner with Medpace operations to promote a culture of continuous improvement;
* Coordinate and conduct internal system audits and external investigative site/vendor audits;
* Create, maintain, and revise departmental Standard Operating Procedures, forms, and templates;
* Develop training materials and applicable tests and guides;
* Work with outside clients/sponsors.
* Host Sponsor audits and Regulatory Inspections
* Act as QA Project Leader, managing timelines and coordinating workload amongst QA Auditors

Qualifications:

* Bachelor's degree in life sciences or nursing;
* 2 or more years of experience in a QA GCP department in a related industry;
* Experience of GCP site audits and vendor audits is highly preferred
* Excellent written and verbal communication skills
* Exceptional teamwork skills
* Ability to work independently.

Travel: Average of 50% across Europe
			
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