Senior Quality Specialist - HCM
Core
Support and maintain the Quality Management System (QMS) to ensure compliance with GDP, GMP, and local regulatory requirements for pharmaceutical products.
Role type
Senior Quality Specialist (Pharmaceuticals)
Builds
Quality oversight, complaint handling, investigations, and third-party quality management for prescription medicines.
Domain
Biopharmaceuticals / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Assurance, Quality Management Systems (QMS), GDP/GMP compliance, product quality oversight, complaint handling, investigations, CAPA management, batch review & release, quality documentation, third-party quality management, audit support, KPI monitoring, trend analysis, continuous improvement, SOP compliance, health authority collaboration
Preferred skills
None stated
Technologies
None stated
Responsibilities
Manage product quality complaints, investigations, deviations, and CAPA activities; Maintain local QMS processes and quality documentation; Coordinate quality activities with internal stakeholders, manufacturing sites, and external partners; Manage quality agreements and oversee compliance of third-party service providers; Support audits, self-inspections, regulatory inspections, and onsite assessments; Monitor quality KPIs, conduct trend analysis, and drive continuous improvements; Deliver quality training and promote compliance with SOPs and quality standards; Collaborate with health authorities and stakeholders on product quality matters
Seniority
Senior, hands-on IC
