Auditor, Computer Systems Quality Assurance
4 weeks ago
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.
Job Responsibilities- 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.
- 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 Assisting Auditor on team-based Syneos Health audits.
- Serves as a trainer and mentor to less experienced QA auditors.
- Requires a Bachelor's degree in the science/health care field or equivalent with 5 years experience in GxP quality assurance auditing in the Pharma or CRO sector.
- Previous experience in the conduct of multiple audit types (e.g. vendors, process, computer system validation).
- Previous experience in supporting customer audits or regulatory inspections in a plus.
- Excellent Knowledge of GxP regulatory requirements with inn depth knowledge of Computer Systems Quality.
- Knowledge of ISPE GGAMP5 concepts is preferred.
- 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
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Québec, Quebec, Canada Syneos Health Full timeAbout the RoleSyneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.As a Senior Auditor, Computer Systems Quality Assurance, you will play a critical role in ensuring the quality and...
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Québec, Quebec, Canada Syneos Health Full timeAbout the RoleSyneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.As a Senior Auditor, Computer Systems Quality Assurance, you will play a critical role in ensuring the quality and...
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