Вакансия на удаленке.
В исследовательскую организацию Syneos Health требуется Sr Auditor (Clinical Trials).
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. Leads with a product development mindset, seamlessly connecting capabilities to add high-value insights to speed therapies to patients and provide practical value to help customers achieve their objectives.
Job responsibilities:
Syneos Health Audits:
- Plans and conducts assigned audits
- Performs For Cause audits
- Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management
- Reviews responses to audit findings for appropriateness and completeness
- Closes assigned audits
Customer Audits/Inspections:
- Prepares for and hosts or supports customer audits
- Prepares for and hosts or supports Regulatory Authority Inspections
Other:
- Serves as Lead Auditor on team-based Syneos Health audits
- Serves as a trainer and mentor to less experienced QA auditors
Supervision:
- Requires minimal instructions on day-to-day work and new assignments
Other tasks:
- May write, review or revise QA Standard Operating Procedures (SOPs) / Work Instructions (WIs)
- Performs other work-related duties as assigned
- Moderate travel may be required (up to 50%)
What company is looking for:
- Requires a Bachelor’s degree in the science/health care field or equivalent with extensive experience in GxP quality assurance auditing
- Previous experience in the conduct of multiple audit types (e.g. vendors, investigator sites, trial master files, data management, safety reporting and laboratories) is preferred
- Excellent Knowledge of GxP regulatory requirements
- Knowledge of Medical and technical terminology related to the audit types to be conducted
- Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency)
- Able to handle multiple tasks to meet timelines in dynamic environment
- Strong organizational, presentation and interpersonal skills
- Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds
- Ability to negotiate, problem solve and provide constructive feedback
- Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation