QA Specialist
Core
Operational Quality Assurance Specialist ensuring compliance with quality rules in liquid formulation manufacturing, managing quality events, and supporting product market launch.
Role type
Senior IC Quality Assurance Specialist (Pharmaceutical Manufacturing)
Builds
Liquid formulation products for global patient populations
Domain
Biopharmaceuticals / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, corrective action implementation, quality documentation review, batch release confirmation, aseptic process knowledge, complex data analysis, BPF/BPD process knowledge
Preferred skills
Project coordination, stakeholder communication, training initiative leadership
Technologies
SCADA systems, BOCCARD systems, PAI (Pharmaceutical Automation Initiative), B44/B52/B33/B52 systems
Responsibilities
Manage quality events and implement corrective actions, conduct on-site quality interventions and audits, review and approve quality and production documents, support project deployment with quality expertise, confirm commercial batches
Seniority
Senior, hands-on IC
