Quality Specialist II (Bloemfontein or Centurion, South Africa)

Job Purpose:

Support the continuous improvement of key components of the Quality Management System (QMS) and related standards. Work with QSPM leadership to assess and report on the functioning of components constituting the QMS. Support the generation and review of Controlled Documents.

• As assigned, complete QSPM goals for the key QMS elements, including, specifically related to Regulatory Intelligence and Risk Management work.

• 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 where appropriate.

• Support Operations staff in the use of automated quality systems; summarize automated quality system reports and provide metrics as appropriate.

• Support the review of Parexel Controlled Documents.

• Assist in the maintenance of the relevant website, Parexel Connect page and filing areas, as needed. Support Parexel Quality in the preparation for and follow up of internal/external audits and inspections as required.

• Work with Parexel 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

• Ability to analyze and interpret data

• Attention to detail and 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 verbal)

Knowledge and Experience:

• Relevant experience in the 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, preferredQualificationsKnowledge and Experience:

• Relevant experience in the Clinical Research field (pharmaceutical industry or CRO) required

• Knowledge of Good Practices (GxP) compliance required

• Regulatory Intelligence / awareness experience preferred (i.e. experience in monitoring, prioritizing and cataloguing industry regulatory news)

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

• Ability to analyze and interpret data

• Attention to detail and 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 verbal)

Education:-

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

• Master’s degree in a science, technology or industry related discipline, preferred