Senior Specialist, External Quality Assurance (EQA)
Core
Ensuring pharmaceutical products manufactured at external entities are produced, tested, packaged, stored, and distributed in compliance with regulatory requirements and company policies.
Role type
Senior Quality Assurance Specialist / Qualified Person (QP)
Builds
Certified pharmaceutical batches and compliant manufacturing processes
Domain
Pharmaceutical manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global GMP knowledge, batch release certification, deviation investigation, regulatory filing compliance, supply chain verification, quality metrics analysis
Preferred skills
EU QP licensee experience, regulatory inspection participation, change management of batch records
Technologies
GMP systems, batch record management tools
Responsibilities
Certify batch compliance as Qualified Person (QP), oversee external entity manufacturing quality, evaluate and release products, analyze quality metrics for process improvement, review batch documentation and deviations, ensure compliance with domestic and foreign regulations
Seniority
Senior, hands-on IC with regulatory oversight
