We are seeking a highly experienced Subcontractor – Senior OTC Compliance Auditor with a background as a former FDA Investigator/Inspector. This short-term assignment (May-August 2026) requires expertise in OTC drug manufacturing, cGMP compliance, and FDA inspection methodology.
As a subcontractor, you will support audits, inspection readiness activities, and compliance reviews for clients in the OTC pharmaceutical industry.
Key Responsibilities
- Conduct cGMP compliance audits of OTC drug manufacturing, packaging, labeling, and laboratory operations.
- Apply FDA inspection methodology to identify compliance gaps, risks, and deficiencies.
- Prepare detailed, professional audit reports outlining observations and recommended corrective actions.
- Support clients with mock FDA inspections, inspection readiness activities, and compliance remediation.
- Review quality systems, SOPs, batch records, data integrity controls, and laboratory practices.
- Represent the organization professionally during international client engagements.
- Manage scheduling, travel, and deliverables independently as an external contractor