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Sr Auditor, QA - CSV (Computer System Validation)

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

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

• Plans and conducts assigned audits.
• Performs auditing of vendor's CSV (Computer System Validation).
• 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 including 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%).

• Requires a Bachelor’s degree in the science/health care field or equivalent with extensive experience in GxP quality assurance auditing.
• GCP experience
• Computer System Validation experience
• Vendor Audit experience
• Process Audit experience
• 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.

Get to know Syneos Health

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Syneos Health (Nasdaq:SYNH) 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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.