【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's Osaka facility.
Role type
Senior IC Quality Compliance Specialist (Pharmaceutical Manufacturing)
Builds
Regulatory submissions to PMDA, quality agreements, and manufacturing licenses for new and existing pharmaceutical products.
Domain
Pharmaceutical manufacturing / Quality Assurance / Regulatory Compliance
Required skills
Change management, GMP compliance audits, Foreign manufacturer certification, Quality agreement management, Deviation management, Document control, NPI project support, Pharmaceutical laws (Act on Pharmaceuticals, Medical Devices, etc.), GQP/GMP knowledge, English (reading, writing, phone conferences)
Preferred skills
Pharmaceutical manufacturing site experience (QA/QC/Production), ADC/Nucleic acid/Regenerative medicine modality knowledge, Low Code/No Code or Generative AI experience, Pharmacist license
Technologies
MS Power Platform
Responsibilities
Evaluate change proposals for regulatory impact and execute required actions; conduct GMP compliance surveys for new/approval changes/periodic reviews; maintain foreign manufacturer certifications and manufacturing licenses; draft and revise quality agreements; evaluate deviations and ensure product quality before market release; maintain SOPs and quality standards; review CTD and application drafts from a quality perspective for NPI projects.
Seniority
Senior, hands-on IC
