Quality Assurance Scientist

Clinigen; Pretoria; On-site; ZAR 300 000 - 420 000; Full time

Job summary

A leading pharmaceutical company in Pretoria is seeking a Quality Assurance professional to support operational excellence and implementation of quality management systems. Candidates should have a matriculation certificate, a BSc degree is advantageous, and at least 3 years of experience in quality assurance within the pharmaceutical industry. The role requires proficiency in Microsoft Office Suite, valid driver's license, and strong attention to detail. The company offers contributions towards medical aid and performance bonuses.

Benefits

Company contribution towards Medical Aid

AlexForbes Pension Fund

Group Life Insurance

Performance Bonus

Qualifications

• Experience within quality assurance role in a pharmaceutical environment is strongly preferred.
• Knowledge of Quality Systems for Pharma, Warehouse, and Distribution according to cGMP and ISO 13485:2016.
• Proficient with change controls, non-conformances, CAPAs and risk management procedures.

Responsibilities

• Support operational excellence within the Quality Management System (QMS).
• Manage tasks including change controls, non-conformances, and complaints.
• Prepare and manage internal and external audit programs.

Skills

Attention to detail

Interpersonal skills

Time management

Initiative

Education

Matric (Grade 12)

BSc degree (advantageous)

QA Qualification

3+ years experience in pharmaceutical QA

Tools

Microsoft Office Suite

Job description

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.

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

Company Contribution towards Medical Aid

• Company Contribution towards Medical Aid
• AlexForbes Pension Fund
• GroupLife
• Performance Bonus