Shift QA Specialist
Core
Ensure quality and compliance standards across manufacturing operations for pharmaceutical diagnostics products, supporting batch release and resolving quality issues.
Role type
Shift QA Specialist (Pharmaceutical Manufacturing)
Builds
Contrast media and radiopharmaceutical imaging agents for diagnostic pathways in neurology, cardiology, and oncology.
Domain
Pharmaceutical manufacturing / Radiopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, batch record review, deviation investigation, CAPA implementation, change control management, regulatory documentation, GEMBA walks, root cause analysis, pharmaceutical legislation knowledge
Preferred skills
Cross-functional collaboration, risk-based decision-making, continuous improvement, troubleshooting
Technologies
QMS, GEMBA, SOPs, validation documentation
Responsibilities
Ensure compliance with GMP and regulatory requirements; represent Quality at Tier 1&2 meetings; conduct spot checks on GMP/GDP documentation; complete batch record reviews; provide governance oversight for housekeeping GEMBA processes; lead instruction monitoring meetings; support escalations and troubleshooting; lead cross-functional continuous improvement teams; lead root cause investigations and CAPA actions; review and authorize documentation (SOPs, change controls, batch release); support shutdown and startup compliance; manage site metrics.
Seniority
Mid-level, hands-on IC