Auditor II, QA (Good Pharmacovigilance Practice exp required)

Job Title

Auditor II, QA (Good Pharmacovigilance Practice exp required)

Job Summary

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

Job Responsibilities

General Profile

• 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. Assists senior QA personnel in hosting or supporting Regulatory Authority Inspections.

Supervision

• Requires some instructions on day-to-day work and new assignments.

Other tasks

• Performs other work-related duties as assigned. Moderate travel may be required (up to 50%).

Qualifications / Requirements

• Requires a Bachelor's degree in the science/health care field or equivalent with moderate experience in GCP quality assurance auditing. Good knowledge of GCP 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; SharePoint proficiency).
• Able to handle multiple tasks to meet timelines in a dynamic environment. Strong organizational, presentation and interpersonal skills.
• Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds.
• Ability to negotiate and provide constructive feedback.
• Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation.

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