Senior Specialist - Quality
Core
Ensures compliance with regulatory standards and cGMP for analytical standards and change control activities across new products, packaging, and outsourcing in pharmaceutical manufacturing.
Role type
Senior Specialist - Quality & Compliance (Analytical Change Control)
Builds
Compliant pharmaceutical supply chain for customers and patients
Domain
Pharmaceutical manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical standards management, Change control processes, cGMP compliance, Regulatory requirements knowledge, Technical writing, Document review, Stakeholder coordination, Problem solving, Decision making, Computer proficiency
Preferred skills
Advanced problem solving, Creative thinking, Consensus building, Industry trend awareness, Optimization of functional performance
Technologies
CAIT system
Responsibilities
Maintain and issue clear Analytical Standard documents for active ingredients and final products; Review and approve change controls to ensure regulatory compliance; Collaborate with stakeholders to implement analytical changes globally; Monitor compendial publications and determine implementation paths; Escalate change control issues to remove bottlenecks; Ensure alignment across subject matter experts for global implementation.
Seniority
Senior, hands-on IC
