Sr QA Specialist - Quality Risk Management
Core
Provide technical leadership and oversight within GMP manufacturing environments to ensure compliance with global regulatory requirements and strengthen quality systems.
Role type
Senior Quality Specialist (Quality Risk Management)
Builds
Safe and effective pharmaceutical/biotech products
Domain
Pharmaceutical/Biotech manufacturing, GMP, Regulatory Compliance
Deliverable
client delivery
Required skills
GMP quality systems expertise, risk assessment methodologies, deviation investigation, root cause analysis, CAPA management, regulatory compliance knowledge (FDA/EMA), data integrity principles, computer system validation
Preferred skills
Medical device experience, hosting regulatory inspections, customer audits, change control, document control
Technologies
Standard office software
Responsibilities
Conduct risk assessments using quality risk management principles, Lead and support deviation investigations including root cause analysis, Manage CAPAs to ensure effective and timely resolution, Ensure compliance with FDA, EMA, and global regulatory standards, Support and host regulatory inspections and customer audits, Collaborate with manufacturing, validation, and engineering teams to drive continuous improvement
Seniority
Senior, hands-on IC
