Senior QA Specialist, CVRM
Core
Provide Quality oversight for all manufacturing and warehouse operational activities, support functions, and directly collaborate with cross-functional partners to guarantee strict adherence to quality standards in a sterile drug product manufacturing facility.
Role type
Senior QA Specialist (GxP Manufacturing)
Builds
Aseptic drug product manufacturing operations and quality systems
Domain
Pharmaceutical manufacturing (Cardiovascular, Renal, and Metabolism medicines)
Required skills
Quality Assurance oversight, Root cause analysis, CAPA management, Regulatory compliance (EU Annex 1, FDA/EMA), GxP digital tools (SAP, MES), Quality Risk Management, Technical writing
Preferred skills
Master's degree, Sterile drug product manufacturing experience, Lean quality practices
Technologies
SAP, MES
Responsibilities
Provide direct oversight of compounding, filling, visual inspection, device assembly, packaging, clean utility generation, and warehouse activities; Serve as QA center of excellence for major investigations, CAPAs, and effectiveness checks; Participate in equipment and process risk assessments and approve operational change controls; Perform incoming goods release, intermediate & finished product release, and review of all manufacturing activities; Approve site procedures and drive operational efficiency by evaluating and refining processes and SOPs; Support inspection readiness and participate during regulatory inspections; Provide QA oversight for sample management and analyze quality data.
Seniority
Senior, hands-on IC