About the job
Core
Establishing and operating a Quality Assurance (QA) system to ensure data integrity, compliance with GxP regulations, and product quality throughout drug development and commercialization.
Role type
Senior Quality Assurance Specialist (Pharmaceutical R&D)
Builds
Robust QA systems, validated computerized systems, and reliable R&D data for regulatory submissions.
Domain
Pharmaceutical R&D / Regulatory Compliance / Data Integrity
Required skills
GMP/QMS operation, Quality Risk Management, Data Integrity (ALCOA+), Regulatory Inspection readiness, CSV validation, AI/ML platform oversight, English (OPIC IH+), Bachelor's degree in Life Sciences/Pharmacy.
Preferred skills
CRO/external vendor management, AI/ML platform adoption in R&D, Digital governance.
Technologies
GMP/QMS systems, AI/ML platforms, Computerized Systems (CSV).
Responsibilities
Manage the R&D data lifecycle ensuring traceability and integrity; Review and approve Validation Plans, Risk Assessments, and Test Protocols for CSV; Conduct internal audits and prepare for regulatory inspections; Oversee AI-generated results documentation and human oversight systems.
Seniority
Senior, hands-on IC