Quality Specialist

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

Due to a growing portfolio, we are currently looking for a Quality Specialist to be based in South Africa with flexible working hours.

At Parexel, the Quality Specialist role offers the opportunity to:

Quality Management System Oversight (QMSO) Support

• As assigned, complete QMSO goals for the key QMS elements.
• Maintain a familiarity with Parexel QMS-related applications and related processes.
• Participate in projects and initiatives as assigned, including reporting information and escalations as needed.
• Remain informed about developments in relevant regulations and guidelines.
• Provide technical knowledge on the electronic Quality Management System (eQMS) TrackWise.

• Support Operations staff in the use of electronic quality systems; summarize automated quality system reports and provide metrics as appropriate.
• Support the review of QMS processes.
• Assist in the maintenance of the relevant website, Parexel Connect page and filing areas, as needed.

Parexel Quality Department Support

• Support Corporate Quality in the preparation for and follow up of internal/external audits and inspections as required.
• Work with Corporate Quality to develop and/or update quality/process documents, tools, and templates.
• Maintain a positive, results oriented work environment
• Communicate in an open, balanced and objective manner.

Skills:

• Excellent interpersonal, verbal and written communication skills
• Customer focused approach to work
• A flexible attitude with respect to work assignments and new learning
• Ability to manage and prioritize tasks efficiently and accurately
• Willingness to work in a matrix environment and to value the importance of teamwork
• Understanding of audit/inspection process
• Ability to lead projects and teams
• Strong ability to analyze and interpret data
• Attention to detail and advanced organizational skills
• Ability to work independently and take ownership of and responsibility for work assigned
• IT literate – Experience with Microsoft based applications and a general knowledge of PC functions
• Culturally aware and ability to think and work globally
• English proficiency (written and oral English)

Knowledge and Experience:

• Extensive experience in a Clinical Research field (pharmaceutical industry or CRO) or other relevant experience in the areas of QMS support required
• Knowledge of Good Practices (GxP) compliance required
• Project Management / Technology / Business Operations experience, as appropriate, preferred

Education:

• Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred.

A little about usParexel is proud to be a leading Clinical Research Organization with colleagues across the globe.

As a member of our team, you’ll get to know your coworkers on a personal level. Have a question? A clinical research leader, project team member, technology “super user” or collaborator are a phone call away. Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations.

Parexel will offer you world class technology and training catered to your individual experience.

If impact, flexibility, and career development appeal to you, Parexel could be your next home.