Sr Auditor, QA

3 semanas atrás

São Paulo, São Paulo, Brasil Syneos Health Tempo inteiro
Sr Auditor, QA - CSV (Computer System Validation)

Sr Auditor, QA - CSV (Computer System Validation)

Responsibilities
  • 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. 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%).
Qualifications
  • 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: Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

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