Principal QA Specialist (Multi-dose pens), CVRM
Core
Principal QA Specialist ensuring quality oversight for manufacturing and supporting processes (cartridge filling, inspections, assembly, packaging) in a new aseptic drug product facility.
Role type
Principal QA Specialist (Manufacturing)
Builds
Aseptic drug product manufacturing facility for next-generation metabolic medicines (obesity, Type 2 diabetes).
Domain
Pharmaceutical manufacturing (CVRM: Cardiovascular, Renal, and Metabolism)
Required skills
Quality by Design, Risk-based operational focus, GMP compliance, Deviation management, CAPA, Root cause analysis, Regulatory inspection support, SAP/MES expertise, Change control, Cleanroom process oversight
Preferred skills
Graduate degree in scientific discipline, 8-10 years GxP experience, 4+ years sterile drug product manufacturing, Strategic systems thinking, Technical writing
Technologies
SAP, MES, Manufacturing Execution Systems
Responsibilities
Support establishment of operational procedures for cartridge filling through packaging; Approve procedures and drive continuous improvement; Design recipes and Manufacturing Batch Records for MES/SAP; Design logic for Release by Exception; Support equipment and process design reviews, FAT, SAT and commissioning; Support or lead complex investigations and approve Deviations/CAPAs; Provide oversight of filling, visual inspection, device assembly, packaging, and clean utilities; Serve as Quality Assurance Owner for digital transformation applications.
Seniority
Principal, hands-on IC with strategic oversight