Spclst, Quality Systems & Compliance
Core
Specialist supporting GQP Quality Assurance activities for a Marketing Authorization Holder, ensuring compliance with global requirements and regulations.
Role type
Specialist, Quality Systems & Compliance (Pharmaceutical)
Builds
Compliant pharmaceutical products and processes for the Japanese market
Domain
Pharmaceutical industry, Quality Assurance, Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP Compliance, Pharmaceutical Quality Assurance, Pharmaceutical Regulatory Compliance, Quality Improvement Programs, Quality Management, Regulatory Compliance
Preferred skills
CAPA management, Deviation investigation, Change control, Self-inspection programs, Computer System Validation
Technologies
GQP systems, Computerized Systems Validation tools
Responsibilities
Plan and execute quality assurance activities ensuring compliance with GQP regulations and company policies; Participate in audits and regulatory inspections as a subject matter expert; Manage CAPA generation, documentation, and root cause analysis; Coordinate product market release activities and monitor release schedules; Maintain Quality Standard Codes and review Quality Agreements with manufacturers; Coordinate GQP training programs and analyze effectiveness metrics; Support Computer System Validation activities for GQP systems; Collaborate with Regulatory Affairs, Pharmacovigilance, and manufacturing sites on cross-functional projects; Support new product launch readiness and regulatory GMP compliance inspections.
Seniority
Individual Contributor, Specialist level
