Quality Specialist I (Bloemfontein, Centurion or Home-based, S.A.)

Job Purpose:

Provide quality oversight support to project team management throughout assigned projects. Specifically responsible for the conduct of remote quality evaluations to proactively identify and address potential quality risks or issues, quality consultation, CAPA support, audit and inspection support. Communicate results to the project team (PM, PL, FLs). Collect, review, analyze and report project quality metrics as assigned.

Work with Early Phase Project Quality and Risk Management, Process Owners, Lead Authors and Operations staff to develop and/or update processes and controlled documents.

Consider process for effectiveness measurement.

• Coordinate the review of Parexel Controlled Documents; summarize and collate responses.

• Support Project Quality and Risk Management and Operations staff in coordination, preparation for and follow up of internal and external audits and inspections, as requested.

• Provide support to Operations staff on the application of, and adherence to processes and day to day use of Parexel processes and systems.

• Identify areas for efficiency gains and process improvements within Operations and Quality groups, with subsequent development and implementation of action plans.

• Represent Early Phase and Corporate process improvement initiatives, as needed.

• Work closely with Early Phase Project Quality and Risk Management, Process Owners, Lead Authors, other Quality groups and Operations staff to ensure continuous process improvement. Support creation, revision, maintenance and re-engineering of training curricula

• Work with the relevant training functions including Parexel Academy / Learning & Development and Operations. Assist with the development or enhancement of training materials as assigned.

• Contribution to the development of training materials Establish and maintain good and efficient communication lines within team, Early Phase Project Quality and Risk Management, Process Owners, Lead Authors, Operations staff and other Quality and functional departments, as appropriate.

• Adhere to adequate communication and/or escalation processes within Early Phase Quality Management and other Quality/Operational/Functional departments, as applicable.

• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner. Maintain compliance with training curriculum. • Consult process SMEs as necessary for guidance.

• Share lessons learned across Early Phase Quality Management as well as with other Quality/Operational/Functional groups outside Early Phase Quality Management, as applicable.

• Maintain a familiarity with Parexel project-related systems and related processes.

• Remain informed about developments in relevant regulations and guidelines. Identification of process gaps and/or improvement opportunities.

• Report process gaps and participate in implementation of process improvement.

• Work closely with Operational management and with Line Manager to ensure continuous process improvement, as assigned

Where assigned, work with Operational groups to provide expert review of client-defined processes/quality and/or training materials.QualificationsKnowledge and Experience:

• Relevant experience (e.g., in the pharmaceutical or CRO industry or in the Technology field).

• English proficiency (written and oral)

Education:

• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience. Excellent interpersonal, verbal and written communication skills

• Client focused approach

• 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 attention to detail and strong organizational skills

• Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization

• IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions Relevant experience (e.g., in the pharmaceutical or CRO industry or in the Technology field).

• English proficiency (written and oral English)

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