| Quality Assurance Auditor | |
| INC Research Central -Easteren Europe, Romania Ref: EP063-02 |
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The RoleThe RoleQuality Assurance Auditor Global Quality Assurance Central and Eastern Europe Provide on-going assessment of the status of the compliance of INC Research Europe operations with regulatory, procedural and contractual requirements. ESSENTIAL JOB FUNCTIONS: 1. Conduct, report and follow-up audits of projects and operational areas in accordance with approved schedules, procedures and formats. Emphasis placed on, but not limited to: - investigator site audit - trial master file review - vendor audit - internal process audit 2. Schedule and manage personal workload in alignment with central plan and departmental objectives. 3. Maintain current awareness of regulations and guidelines relating to the conduct of clinical trials in Europe. 4. Advise operational staff with regard to regulatory requirements and appropriate corrective and preventive actions in response to audit findings and the remediation of operational situations. 5. Host and report on sponsor audits and regulatory inspections of INC Research in Central and Eastern Europe, in accordance with approved procedures and management direction. OTHER RESPONSIBILITIES: Perform other work-related duties as assigned. EDUCATION/SKILL/EXPERIENCE REQUIREMENTS: BSc/BA degree or equivalent in a scientific or healthcare discipline. Extensive experience applying GCP in a clinical trials environment, either as monitor or auditor. Strong knowledge of GCP regulations, legislation and guidelines, plus awareness of other GxP requirements relevant to the conduct of clinical trials. Understanding of data management practices would be an advantage. Must be fluent in written and spoken English, with appropriate medical/technical vocabulary. In addition to native language, working knowledge of at least one other Eastern European language would be an advantage. Must be able to operate as part of a team, while also performing autonomously in a dynamic environment. Effective organisational and time management skills required. Well-developed interpersonal and communications skills, with ability to communicate clearly, concisely and accurately using both spoken and written word. Computer literacy essential. Proficient in use of Microsoft Word, Access, and Excel, together with e-mail and Internet packages. Willing and able to travel internationally for a minimum of 50% of time. |
RequirementsRequirementsExtensive proven knowledge in applying GCP in a clinical trials environment, either as monitor or auditor Must have experience in engaged guide line |
About the CompanyAbout the CompanyWe are an organization composed of therapeutically-focused high performance teams led by world-class project managers and leaders, dedicated to helping our Customers bring products to market in order to improve world health |
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