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Clinical QA Specialist
A company is looking for a Clinical QA Specialist (Contract). Key Responsibilities Supports QA oversight and GCP compliance of study activities in collaboration with cross-functional teams Performs study audits and maintains study TMFs and their systems Advises stakeholders on GCP compliance issues and prepares KPIs for performance monitoring Required Qualifications Bachelor's degree, preferably in health-related sciences 1 - 3 years of relevant technical experience in the pharmaceutical industry Thorough knowledge of ICH Good Clinical Practices (GCP) and related regulations Functional knowledge of GMP requirements, especially IMP GMP Understanding of Computer System Validation / Assurance requirements (CSV/CSA)
A company is looking for a Clinical QA Specialist (Contract).
Key Responsibilities
Supports QA oversight and GCP compliance of study activities in collaboration with cross-functional teams
Performs study audits and maintains study TMFs and their systems
Advises stakeholders on GCP compliance issues and prepares KPIs for performance monitoring
Required Qualifications
Bachelor's degree, preferably in health-related sciences
1 - 3 years of relevant technical experience in the pharmaceutical industry
Thorough knowledge of ICH Good Clinical Practices (GCP) and related regulations
Functional knowledge of GMP requirements, especially IMP GMP
Understanding of Computer System Validation / Assurance requirements (CSV/CSA)
