Job Description

Bloemfontein, South Africa
Additional Locations: Bloemfontein, Free State, South Africa
Job ID R0000017608 Category Quality Management

ABOUT THIS ROLE

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.)

xe2x80xa2 English proficiency (written and oral) xe2x80xa2 Significant industry experience in one or more areas of PQRM support and / or Quality Management

• IT literate - experience with Microsoft based applications and functional and TMF applications / languages / solutions. Able to embrace new technology and apply best practices

Skills:

• Emerging ability to lead without explicit authority
• Self-management: independent, takes initiative, proactive and organized
• Focused on quality results - attention to detail and First Time Quality
• Interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback
• Ability to develop professional, collaborative relationships both within Quality and with Operations (and clients where assigned)
• Skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues
• Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge
• Cultural awareness with the ability to think and work, globally
• Ability to travel as needed for the position

Education:

• Bachelorxe2x80x99s Degree or other relevant experience required. Life-science, health or industry-related discipline preferred