Job Description

One of the conditions under the Protection of Personal Information Act 4 of 2013 (POPIA) provides that candidates have the right to be informed about the collection and use of their personal information,
In the course of your application: we may

• collect personal information that may be used to identify potential professional opportunities other than the job you have applied for but of which we think might be of interest to you.
• use your Personal Information to confirm references or background checks you have provided us.
• request your consent to participate in aptitude tests or recruitment assessments.

We also use your personal information to respond to your inquiries, to verify your information and to share information with you.
Your personal information will be securely stored by the Human Capital Department and it will be retained for a period of up to 12 months as of the closure of the application procedure if your application is unsuccessful, and in case of a successful application and you are hired, your data will be transferred to your personal employee file.
By applying for this position, you consent to us processing your personal information.
We reserve the right to make an appointment. If you have not heard from us within 30 (thirty) days of the closing date, please accept that your application was unsuccessful. Correspondence will be entered into only with shortlisted candidates.
Job Purpose:
The QA Coordinator is responsible for the investigation of customer complaints, ensuring product quality and compliance with relevant regulatory requirements. This role includes the analysis and resolution of product defects, preparing and compiling detailed reports for internal and external stakeholders. The coordinator will also track and report on complaint trends, participate in continuous improvement initiatives, and train junior staff as required.
Key outputs:
Complaint Investigation and Documentation:

• Characterise and document the nature of each complaint, adhering to Procedure 20-06-03-020 and or 20-06-06-021
• Conduct visual inspections of returned samples and assess their condition upon receipt
• Review batch documentation to identify any potential issues that occurred during manufacturing or QC testing
• Perform functional testing of returned samples to confirm validity of reported complaint and identify potential quality defects
• If necessary, initiate chemical testing through the Chemistry Lab and biological testing for affected products
• Alert relevant departments or senior personnel of identified issues and request corrective actions
• Compile a comprehensive complaint report detailing investigation findings and corrective actions, for review by the QA Release Manager and/or QA Manager
• Ensure all complaint documentation is filed appropriately, with copies sent to relevant personnel in Marketing, Sales, and Production
• Track product defects and calculate Complaints Incidents Per Million (CiPM) for the monthly or quarterly period, updating the system.

Reporting and Analysis:

• Compile monthly/quarterly complaint summaries, detailing trends, corrective actions.
• Identify recurring issues by analysing historical complaint data and similar occurrences within the last 12 months
• Maintain a clear record of inventory data related to the batch in question

Training and Development:

• Train new trainees or junior staff on specification 20-06-03-020 and 20-06-03-021 and other relevant procedures
• Share knowledge and expertise in quality assurance procedures with the team to ensure compliance to SOP.

Collaboration and Continuous Improvement:

• Work closely with cross-functional teams (Marketing, Sales, Production, etc.) to ensure customer complaints are addressed promptly

• Participate in assigned projects and continuous improvement initiatives as outlined in MBOs (Management by Objectives)
• Provide regular feedback to relevant departments to enhance quality standards and improve processes

• Matric (Grade 12)
• Diploma in Public Relations or similar will be advantageous

• Training in Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), or equivalent regulatory standards
• A minimum of 1-2 years' working experience in a pharmaceutical manufacturing environment will be advantageous
• Experience in Quality Assurance (QA), particularly in product complaint investigations and customer service within a regulated industry will be advantageous

• Ability to manage multiple complaints investigations simultaneously with focus on prioritizing the critical complaints, while maintaining high attention to detail and quality standards
• Understanding of QA software systems, data management, and report generation
• Knowledge of ISO 9001, ISO 13485, and other quality management system standards
• Clear communication skills, both verbal and written, to interact with internal teams and customers.
• A strong commitment to continuous learning and professional development in quality assurance and regulatory compliance