Senior Quality Specialist

Parexel

Bloemfontein

We are currently looking for an experienced Quality Specialists to be based in South Africa.

Your time here

At Parexel, Quality Specialists act as a Quality partner for GDO Biostatistics and Statistical Programming, focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the execution of quality SOPs to support operations, leadership and clients
• Manage the relationship with GDO Biostatistics and Statistical Programming
• Provide Quality input to audits/inspections
• Facilitate identification, investigation and remediation of Quality Issues (QIs) related to GDO Biostatistics and Statistical Programming activities
• Facilitate the Risk Evaluation process

Knowledge and Experience:

• Knowledge of ICH-GCP and clinical trial regulation

• Experience using root cause methodologies (5-whys, fishbone diagram, etc.)

• English proficiency (written and oral) • Significant industry experience in one or... More Detail

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