Senior Auditor, QA

1 week ago

Singapore SYNEOS HEALTH SINGAPORE PTE. LTD. Full time

Conduct audits to assess compliance with applicable regulations, company policies, standard operating procedures and (SOPs) work instructions (WI), contracts and project-specific requirements. Hosts and supports customer audits and regulatory inspections in accordance with QA SOPs and WIs. Provides guidance to less experienced QA auditors.

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 mínimal 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%).

**Requirements**:

- Requires a Bachelor’s degree in the science/health care field or equivalent with extensive experience in GxP quality assurance auditing.
- 2 years of relevant experience as an auditor in GCP
- 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

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