Pharmaceutical Specialist
Core
Ensuring quality, compliance, and continuous improvement of pharmaceutical manufacturing processes through investigations and root cause analysis.
Role type
Pharmaceutical Specialist (GMP Quality)
Builds
Safe and reliable supply of medicines to patients worldwide
Domain
Biopharmaceuticals / Generics / Neuroscience and Immunology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, deviation handling, root cause analysis (5-Why, Fishbone), CAPA management, risk assessment (FMEA), change control, data analysis, process validation
Preferred skills
Lean/Six Sigma, continuous improvement methodologies
Technologies
GMP frameworks, FMEA, 5-Why, Fishbone
Responsibilities
Lead and support complex deviations, complaints, and non-conformances; Define, implement, and monitor Corrective and Preventive Actions (CAPAs); Ensure adherence to GMP and regulatory requirements; Serve as SME during audits and inspections; Analyze process data and trends to identify risks; Work closely with Operations, QA, QC, and Engineering teams
Seniority
Mid-level, hands-on IC
