Pharmaceutical Quality GCP Auditor – Consulting

This is a fully remote position, open to applicants in South Korea.

📋 Description

• Execute Good Clinical Practice (GCP) audits, including planning, creating agendas, conducting physical or remote audits, and drafting reports.

• Assess compliance and qualifications of investigator sites, CROs, and vendors.

• Develop thorough audit reports that outline findings and root causes.

• Deliver written audit reports in English.

• Offer support for corrective actions and communicate findings to QA leadership and stakeholders.

• Collaborate with clients to uphold quality standards.

⛳️ Requirements

• At least 10 years of experience in Clinical Quality Assurance and/or Good Clinical Practice (GCP).

• A minimum of 5 years of experience in auditing Good Clinical Practices.

• Proven experience with the expectations of regulatory agencies (such as FDA, EMA) and activities related to audit preparedness.

• Demonstrated ability to develop and implement quality assurance strategies, audit programs, and corrective action plans.

• Proficient in English communication, both verbal and written, at a B2 level.

• Proficient in Korean communication, both verbal and written, at a B2 level.

• Bachelor's degree required.

🏝️ Benefits

• Flexible work arrangements.

• Opportunities for professional development.