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Project Quality and Risk Lead I (Bloemfontein, South Africa)

Parexel International Corporation

Bloemfontein, Orange Free State, South Africa

Job Purpose:

Serve as primary project quality expert, point of contact and support to project team leadership

throughout the project.

Manage the Quality Evaluation (QE) workflow.

Communicate results to the project team (PL, FL's).

Provide support with quality issue management, audits and inspections, and

project quality and risk consultancy as required.

Assess operational execution using a risk-based approach to verify adherence to standards and assist with remediation when required.

Facilitate quality related interactions with clients.

Partner with operational delivery teams on first-time quality, robust risk and issue management and maintaining an inspection-ready state.

Provide quality expertise through the execution of quality SOP's to support operations, leadership and clientsQualificationsExperience Required:-

2-5 Years' experience in late phase clinical research, ideally in a Functional Lead role.

Knowledge of ICH-GCP principles English proficiency

Education:

• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience

Skills:

• Good interpersonal, verbal and written communication skills

• Client focused approach

• Ability to act as the main quality contact with clients

• Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning

• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with good organizational skills

• Detail oriented

• Ability to work effectively in a matrix environment and to demonstrate and foster teamwork

• IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions

• Ability to travel approximately 30% - 50%

Job posted: 2021-03-02

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