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

• High attention to detail
• Good interpersonal skills
• Disciplined
• Assertive
• Ability to work under pressure
• Able to use initiative
• Forward thinking and proactive
• Sound time management skills

Benefits

• Company Contribution towards Medical Aid
• Alex Forbes Pension Fund
• Group Life
• Performance Bonus