Syneos health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within corporate is vital to furthering our vision of shortening the distance from lab to life. Discover what our 29,000 employees, across 110 countries already know.
work here matters everywhere
responsibilities
* plans and conducts assigned 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.
* serves as lead auditor on team-based syneos health audits.
* serves as a trainer and mentor to less experienced qa auditors.
* requires minimal instructions on day-to-day work and new assignments.
* 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%).
qualifications
* 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.
about syneos health
over the past 5 years, we have worked with 94% of all novel fda approved drugs, 95% of ema authorized products and over 200 studies across 73,000 sites and 675,000+ trial patients.
additional information
tasks, duties, and responsibilities as listed in this job description are not exhaustive. The company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. The company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. The company is committed to compliance with the americans with disabilities act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
seniorities
* mid-senior level
employment type
* full-time
job function
* quality assurance
* pharmaceutical manufacturing
* research services
mexico city metropolitan area
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