QA Outsource Specialist

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 QA Outsource Specialist to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Degree or Diploma in Biotechnology, Pharmacy, Biological Sciences, or a similar field.
• Audit Certification from an internationally recognized service provider.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• At least 3-5 years of experience in the pharmaceutical/ biotech manufacturing industry doing activities
• related to vendor management.
• At least 2-5 years in Aseptic manufacturing.
• Sound technical ability in the field of operational Quality Assurance.
• Experience in quality and regulatory compliance within a cGMP facility.
• Quality and Regulatory compliance knowledge, i.e., SA GMP, PIC/S, and WHO as well as application
• Business and operational planning.
• Program and project management
• Experience having performed local and international audits.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

• Plan, schedule, and perform audits of sterile manufacturing facilities, equipment, processes, and systems.
• These audits may include but are not limited to sterile manufacturing facilities, drug substance facilities,
• aseptic processing, cleanrooms, and controlled environments. Assess compliance with relevant
• regulations (e.g., PIC/S, WHO, FDA, EMA, GMP, ICH), company policies, and industry standards.
• Identify areas of non-compliance, potential risks, and opportunities for improvement during audits.
• Collaborate with relevant stakeholders to develop corrective and preventive action plans (CAPAs).
• Prepare comprehensive audit reports summarizing findings, conclusions, and recommendations for
• management and stakeholders.
• Stay up to date with changes in regulations and guidelines related to the pharmaceutical industry.
• Collaborate with procurement to conduct audits of vendors, suppliers, and contract manufacturers to
• ensure their compliance with quality and regulatory requirements.
• Specialize in GMP guidelines and good practices within Aseptic manufacturing and provide technical support to other Quality units.
• Provide technical feedback on audit observations in the quality space to align with good practices.
• Provide Technical support to the QA Officers related to international standards, regulations, and guidelines.
• Compliance with all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining ways of working.
• Coach and provide QA leadership to staff with regard to vendor approval and certification.
• Submit appropriate weekly, monthly, and quarterly, quality and operation metrics.
• Write, review, and approve SOPs and Work instructions related to Outsource Section.
• Ensure annual reports are completed where required.
• Review and approve vendor certifications and manage the vendor database and AVL up to date.
• Responsible for maintaining a risk-based approach by reviewing new and approved vendors by conducting vendor quality risk assessments.
• Plan, conduct, and coordinate internal audits including establishing audit teams, peer review of observations and following up with departments on open actions, writing the annual report for internal audits.
• Plan, conduct, and coordinate external (supplier/vendor, customer, and third-party manufacturers) audits including establishing audit teams, peer review of observations, and follow-up of open vendor CAPAs and ensure closure of audit findings.
• Escalate any significant/critical observations to the QARO manager and Head of Quality.
• Responsible for the coordination of regulatory audits, by planning and supporting the Head of Quality and the Responsible Pharmacist during Regulatory audits and ensuring that CAPA plans are in place timeously.
• Review and approve vendor postal audits.
• Create an audit committee to review audits performed on CMOs.
• Compile and Review quality technical agreements for approval for suppliers/vendors, customers, and third-party manufacturers.
• Compile and review contracts for Agents that Biovac exports to.
• Ensure that vendors change notifications from vendors, 3rd party manufacturers are communicated to the site.
• Liaise with other support departments on-site to drive the change notifications from vendors, 3rd party manufacturers.
• Coordinate communication of artwork changes to third-party manufacturers.
• Investigate and compile investigation reports relating to vendor quality complaints.
• Communicate investigations and outcomes of vendor quality complaints to external stakeholders.
• Review and approve vendor monitoring reports.

Application Deadline: 18 October 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.