Quality Assurance Officer

Biovac; Cape Town; On-site; ZAR 350,000 - 500,000; Full time

Job summary

A leading sterile vaccine manufacturer in Cape Town seeks a dynamic Quality Assurance Officer. The role involves ensuring regulatory compliance, coaching teams on quality standards, and participating in quality investigations. Candidates should possess a degree in a relevant field and at least 3 years of QA experience in the pharmaceutical industry. The position offers an opportunity to contribute to a mission-driven organization focused on protecting life.

Qualifications

• At least 3 years' experience in Quality Assurance within the pharmaceutical/biotech industry.
• Experience in quality management systems within a cGMP facility.
• Strong understanding of Quality and Regulatory compliance.

Responsibilities

• Ensure compliance with all applicable regulations and internal procedures.
• Coach and provide QA leadership to responsible areas.
• Participate in investigations of deviations and quality incidents.

Skills

Quality Assurance in pharmaceuticals

Regulatory compliance knowledge

Technical ability in QA

Education

Bachelor's degree or diploma in Biotechnology, Pharmacy, Biological Sciences

Job description

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous Quality Assurance Officer to join a goal-oriented team.

Qualifications Needed

• Bachelor's degree or diploma in in Biotechnology, Pharmacy, Biological Sciences or a similar field.
  
  

Necessary Experience & Industry Knowledge

• At least 3 years' experience in Quality Assurance within the pharmaceutical/ biotech manufacturing industry.
• Experience in quality management systems within a cGMP facility.
• Experience in Production, Quality Control or relevant operational activities.
• Sound technical ability in the field of operational Quality Assurance.
• Quality and Regulatory compliance knowledge, i.e. SA GMP, PIC/S and WHO as well as application.
  
  

Core Technical Delivery

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

• Ensure compliance with all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining the way of working.
• Coach and provide QA leadership to areas of responsibility on quality compliance requirements.
• Contribute to discussion on relevant QA topics and communicate closely with other departments.
• Participate in the investigation of incidents, OOS, deviations, discrepancies, root cause investigations or test failures as required.
• Support allocated operational areas by participating in the implementation of change control.
• Participate in Corrective Actions and Preventative Actions (CAPA) in order to meet compliance requirements.
• Review, approval and closure of incidents in accordance with SOP.
• Review, approval and closure of deviations and escalating to QA Operations Lead where relevant.
• Review, approval and closure of change control for quality and regulatory compliance impact and determine requirements for implementation.
• Review, approval and closure of MDDs and OOSs in accordance with SOP.
• Participate in risk assessments and ensure mitigations are efficacious.
• Ensure risk actions identified are closed timeously.
• Assist in vendor auditing when required.
• Perform internal audits as required, generate reports and follow up for close out of findings.
• Support QA department with Regulatory audits and other 3rd party audits.
• Ensure deep and holistic understanding of allocated area(s) of responsibility to ensure effective closure of critical auditing findings on site.
• Ensure or develop understanding of processes in areas of responsibility to be able to review and sign off quality related documentation, such as SOPs, WI, etc.
• Review batch records for compliance and adherence to GMP.
• Perform QA checks in areas of responsibility and ensure that observations are documented and followed up.
• Review and approve SOPs for responsible areas.
• Review job descriptions of staff within area of responsibility.
• Analyze and write regular trend reports.
• Conduct Quality Forum meetings within area(s) of responsibility.
• Assist in product quality reviews when required.
• Ensure audit readiness.
• Participate in projects as and when required.
• Review and assess incidents raised.
• Review and approval of effectiveness checks.
• Labelling of product/material that is suspect according to internal procedures.
• Ensure overdue QMS documents are followed up timeously and actioned.
• Lead complex deviations/investigations on site to ensure adequate root cause and CAPA identification.
• Providing training on GMP relevant aspects e.g., Quality Events, Change controls, CAPAs and Risk Management
• Review effectiveness of the QMS to ensure the system remains in compliance.
  
  

Internal Application Deadline: 15 August 2025

External Application Deadline: 29 August 2025

If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.

We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.

Disclaimer

Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.