Principal QA Specialist (Assembly & Packaging), CVRM
Core
Principal QA Specialist ensuring end-to-end quality for Assembly, Packaging, and Warehouse operations in a new high-volume drug manufacturing facility.
Role type
Principal QA Specialist (Assembly & Packaging)
Builds
Aseptic drug product manufacturing processes for Cardiovascular, Renal, and Metabolism medicines.
Domain
Pharmaceutical manufacturing (GMP)
Required skills
Quality by Design, Risk-based quality controls, GMP compliance, Deviation/CAPA management, Root cause analysis, SAP/MES integration, Regulatory inspection support, Change control, Continuous improvement.
Preferred skills
Device assembly/packaging experience, Pre-filled syringes/autoinjectors, Advanced GMP/regulatory knowledge, Technical writing.
Technologies
SAP, MES
Responsibilities
Establish operational procedures for Assembly, Packaging, and Warehouse; Approve procedures and drive continuous improvement; Design recipes and Manufacturing Batch Records for MES/SAP; Define logic for Release by Exception; Support equipment/process design reviews and commissioning; Lead complex investigations and approve CAPAs; Support regulatory inspections; Oversee device assembly, packaging, labeling, serialization, and warehouse operations; Approve digital applications for shop-floor transformation.
Seniority
Principal, hands-on IC
