Quality Assurance Scientist

Support the delivery of operational excellence, working in partnership with the business areas to implement improvement opportunities and effective use of the Quality Management Systems.

General

Able to plan effectively to meet set timelines
Identify root-causes of a problem, prioritize and identify solutions
Escalate to management when product quality or patient safety is at risk
Contribute to continuous improvement by formulating reports, trending and data analysis
Support other members from the Quality team
Maintain excellent working knowledge of continuous improvement tools and methodologies

Quality Assurance

Effectively manage the operational tasks within the Quality Management System (QMS) including but not limited to:

Change Controls
Non-conformances/ Deviations
Complaints
CAPAs
Risk Management
Effectiveness
Temperature mapping/ Validation
Vehicle mapping/ Validation

Operations

Create, review and approve relevant standard operating procedures, work instructions and forms
Support as required in internal, external and Regulatory audit programs. This includes report writing and managing of audit observations/ responses
Ensure that appropriate standards of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and ISO 13485:2016 are maintained
Maintain Clinigen paper and electronic records for quality documentation
To communicate relevant aspects of the quality system to employees, as necessary, in order to support product and service quality
Support other members from the Quality team

Requirements

Education

Matric (Grade 12)
BSc degree will be advantageous
QA Qualification
Minimum of 3 years' experience within quality assurance role within pharmaceutical environment strongly preferred

Essential

Proficient in Microsoft Office Suite (Excel, Word, Outlook, etc.)
Valid driver's license with own vehicle
Knowledge and understanding of Quality Systems for Pharma, Warehouse and Distribution and Medical Devices according to cGMP, ISO 13485:2016 and cGDP
Knowledge of Guidelines on GMP, GDP and ISO 13485:2016 of medicinal products and medical devices for human use
Understanding the conditions of the SAHPRA licenses

Skills/ Physical Competencies And Behavioral Qualities Required