【AstraZeneca】【Q&SC】Senior Compliance Specialist,GQP品質保証部
AstraZeneca · Kita-ku, Osaka, Japan · Global
Regulatory Affairs
–
Not yet analysed
Demand76
Career growth66
Healthcare fit42
Remote potential20
5-year outlook
Stable demand for experienced pharma QA/regulatory compliance professionals in Japan; compensation should remain competitive within pharma, though exact pay depends on seniority, location and prior GMP/GQP experience.
Clinical license
Not required
Applicant reach
narrow
Seniority
senior
Employment type
full-time
Date found
2026-10-29
Intelligence details
Flexible work details
- Engagement type
- Permanent
- Hours
- Full-time
Eligibility, licensing, and location restrictions can change. Always confirm details on the source posting before applying.
Why this is worth applying to
Worth considering for pharmacists or QA/RA professionals with pharma manufacturing or GQP/GMP experience; clinicians without industry quality/regulatory background are unlikely to be competitive.
Who should apply
Pharmacists with pharmaceutical QA/QC, regulatory affairs, or manufacturing compliance experience; quality assurance professionals with GMP/GQP, PMDA inspection, change control, deviation/CAPA, or NPI experience.
CV angle
Frame real experience using GQP/GMP language: change control, GMP inspection/PMDA submission support, foreign manufacturer accreditation, quality agreements, deviation/CAPA, document control, CTD review and cross-functional global collaboration. Emphasize pharmacist license and any pharma manufacturing/QA exposure; do not inflate clinical duties into regulatory experience.
Skills to highlight
- GQP/GMP compliance
- Pharmaceuticals and Medical Devices Act (薬機法) knowledge
- Change control
- GMP inspection and PMDA interaction
- Deviation/CAPA management
- Quality agreements and document control
- NPI/CTD quality review
- English/global cross-functional collaboration
Role summary
Senior pharma quality compliance role at AstraZeneca covering GQP/GMP manufacturing-site oversight, change control, GMP inspections, foreign manufacturer accreditation, quality agreements, deviation management, document control and NPI support.
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