Compliance Specialist
Core
Support compliance activities in Auditing, Inspection Readiness, Change Control, CAPA management, Risk Management, Training & PLM oversight for a pharmaceutical/consumer healthcare manufacturing site.
Role type
Compliance Specialist
Builds
Ensures site operations align with HQS, regulatory requirements, ICH, and ISO standards.
Domain
Pharmaceutical / Consumer Healthcare Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance knowledge, CAPA management, internal audit coordination, risk assessment, product lifecycle management, change control oversight, KPI monitoring
Preferred skills
Analytical mindset, attention to detail, ability to influence without authority, organizational planning
Technologies
GMP, ICH, ISO, HQS standards
Responsibilities
Review and assess change controls for quality impact; Coordinate CAPA management and effectiveness checks; Coordinate site internal audit program; Support risk assessments across quality systems; Support site training program monitoring; Support audit readiness assessments; Coordinate site problem solving program; Monitor and update monthly KPI status for compliance activities
Seniority
Mid-level, hands-on IC
