Pharmaceutical Specialist
Core
Ensure pharmaceutical production processes and projects comply with guidelines and procedures; oversee quality, technical, and compliance topics including changes, complaints, deviations, and audits.
Role type
Pharmaceutical Specialist (Quality & Compliance)
Builds
Pharmaceutical production processes and quality management systems
Domain
Healthcare / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, GMP compliance, quality risk management, procedure development, stakeholder management, change control, training delivery, safety and health regulations
Preferred skills
Experience with quality and compliance procedures, creative problem solving, prioritization under pressure
Technologies
GMP, QRM, CAPA, SOP/WI documentation
Responsibilities
Initiate, coordinate, and perform complex quality tasks to support production processes; conduct GMP Gemba walks to ensure inspection readiness; advise Quality Practitioners on product quality impacts of process changes; develop business cases for quality/EHS/productivity improvements; participate in audits and implement safety, health, and environment policies.
Seniority
Mid-level, hands-on IC