Contract Opportunity - Senior OTC Compliance Auditor (Great opportunity for former FDA Inspectors)
Core
Conduct cGMP compliance audits and inspection readiness activities for OTC drug manufacturing clients.
Role type
Senior OTC Compliance Auditor (Subcontractor)
Builds
Compliance audit reports and inspection readiness support for pharmaceutical clients
Domain
Pharmaceutical manufacturing / Regulatory compliance
Deliverable
client delivery
Required skills
cGMP compliance auditing, FDA inspection methodology, OTC monograph expectations, quality system review, SOP and batch record review, data integrity controls, laboratory practice auditing, international client engagement, independent audit management
Preferred skills
Technical writing, clear articulation of findings
Technologies
None stated
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 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; Manage scheduling, travel, and deliverables independently as an external contractor
Seniority
Senior, hands-on IC