【AstraZeneca】【Q&SC】Senior Compliance Specialist,GQP品質保証部
Core
Senior Compliance Specialist ensuring regulatory compliance and quality assurance for manufacturing operations at AstraZeneca.
Role type
Senior Compliance Specialist (Quality Assurance)
Builds
Regulatory submissions, quality agreements, and compliance documentation for pharmaceutical manufacturing.
Domain
Pharmaceutical manufacturing / Quality Assurance / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Change management, GMP compliance audits, Foreign manufacturer certification, Quality assurance agreements, Deviation management, Document control, NPI project support, Pharmaceutical laws (Yakuhi-ho), GQP, GMP knowledge, English (reading, writing, conference calls)
Preferred skills
Pharmaceutical manufacturing experience (QA/QC/Production), ADC/Nucleic acid/Regenerative medicine modalities, Low Code/No Code, Generative AI, Pharmacist license
