Analytical Specialist-Emerging Markets
Core
Support new product submissions, launches, and quality compliance activities for Brazil QC operations.
Role type
Senior Quality Assurance Specialist (Emerging Markets)
Builds
Ensures regulatory compliance and batch release readiness for new submissions in Brazil.
Domain
Pharmaceutical Quality Assurance / Regulatory Compliance
Required skills
GMP compliance, SOP development and review, CAPA management, OOS/OOT investigation, audit readiness, regulatory inspection support, quality review meeting facilitation, method transfer planning, batch release planning, troubleshooting.
Preferred skills
Experience with IPDO team collaboration, Launch team coordination, DRB & Partners interaction, Global SOP streamlining.
Technologies
None stated
Responsibilities
Identify equipment for procurement and support installation/qualification for new submissions; Review and support query responses for new submissions; Coordinate with Launch and QC teams to ensure standards and prerequisites are met before commercial batch receipt; Support method transfers to DRB & Partners; Support QC team in batch release planning, troubleshooting, incident investigation, OOT/OOS analysis, and CAPA tracking; Review documentation practices and SOPs for GMP compliance; Support regulatory and internal inspections and audit readiness; Execute weekly and monthly quality review meetings to track occurrences, OOS, OOT, change controls, complaints, and batch release status.
Seniority
Senior, hands-on IC
