Quality Assurance
Core
Lead technical quality projects and ensure compliance with quality standards in the pharmaceutical industry.
Role type
Senior Quality Assurance Manager (Pharmaceuticals)
Builds
Quality management systems, SOPs, and regulatory compliance documentation for local and corporate activities.
Domain
Pharmaceuticals / Quality Assurance
Required skills
Quality Assurance, GMP/BPF compliance, Supplier qualification, Auditing, Adverse reaction monitoring, KPI tracking, CAPA management, Deviation handling, Internal system management (Trackwise, Hermes), Training organization
Preferred skills
Portuguese language, International project experience, Travel availability
Technologies
Trackwise, Hermes
Responsibilities
Generate and maintain Standard Operating Procedures (SOPs) for local quality and pharmacovigilance activities; Qualify suppliers to ensure manufacturing operations comply with BPF/BPD; Conduct audits; Monitor market complaints and queries from pharmacists, wholesalers, doctors, and patients; Manage adverse reaction reporting systems; Organize training actions for corporate quality tools.
Seniority
Senior, hands-on IC