QA Outsource Coordinator

Job purpose

Responsible for all QA Coordinated related activities including but not limited to:

Vendor File Management

Vendor Monitoring

Administrative support

Continually strive to deliver solutions through teamwork that ensures continuous improvement through innovative solutions.

Maintaining of the QA admin documentation and processes in full compliance with the current regulations and guidelines - both local and international

Participating in project teams and supporting other relevant organizational departments and/or teams.

Participation in quality audits and support to QA team.

Effective implementation / maintenance of quality systems & safety systems

Responsible to ensure that the QA Release and Outsource department and its respective sections deliver services and solutions in alignment with pharmaceutical quality system requirements.

Ensure compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures, and other applicable laws.

Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac.

Continuously support and prescribe to cGMP within Biovac.

Minimum qualification(s)

Required:

Grade 12 / Matric / Equivalent

Recognition is given to Prior Learning and practical experience.

Experience & industry knowledge

Required:

At least 2 – 3 years in similar environment

Pharma/ Biotechnology/ FMCG industry experience is highly advantageous

Good, solid proven working experience in Microsoft office suite including Word, Power point, Excel is required.

Microsoft Access experience will be highly advantageous.

Office and administration work experience required

Knowledge of supplier/vendor auditing advantageous.

Preferred:

Experience in database maintenance

Experience in having faced successfully local and/ or international quality audits.

Experience in aseptic (Sterile) manufacturing.

Business Management

Vendor certification

Keep vendor certification tracker up to date

Follow up with departments on vendor certification approval

Coordinate and facilitate the vendor certification documentation for approval

Issue provisional or approved vendor certificates

Update and maintain AVL

Prepare Vendor Monitoring reports as per the schedule.

Vendor file management

Keep database of vendors and hardcopy files of vendors up to date

Ensure all certificates in file are current and request new one’s from vendors when expired

Send postal audits out to vendors and follow up on outstanding postal audits

Follow up on outstanding site audit reports and observations close out

Vendor Monitoring

Prepare Vendor Monitoring Schedule

Prepare vendor monitoring reports

Source QC results for Vendor monitoring review

Track completion of Vendor Monitoring Reports

External audits

Assist in the coordination and organization of third party and regulatory audits

Assist with departmental documentation preparation for third party and regulatory audits

Assist with company response documentation preparation for third party and regulatory authorities

Ensure all documentation is filed and up to date

General QA administrative Support

Assist with Deviations, CAPAs, Change Controls and justifications

Maintain Vendor Quality Complaints and Vendor Change notification registers.

Compile weekly and monthly Quality slides for QA Vendors and assist QA Release and Outsource with Quality Management Review preparations

Assist with maintaining the Quality and Change Notification Agreement register.

Organizing and scheduling all ad-hoc/ recurring QA related meetings/workshops/teleconferences:

Book venue (including projector, conference phone and stationery required)

Obtain agenda from relevant stakeholders and draft, include in meeting invite.

Arrange any catering where required

Print copies of the minutes for distribution at the meeting

Capture minutes – if required ad hoc:

Forward minutes internally for checks & corrections/additions

Distribute minutes to relevant parties once content confirmed

Photocopying and scanning of documentation

Overseeing all general QA department queries

Assist Senior QA Officer - Vendor Management and Section Heads with gathering of information for communication purposes

Save important correspondences such as pertinent emails, presentations, contracts, quotations, invoices to relevant folders

Maintain project contact list and set up outlook group contact lists

Assist in additional functions as per Business requirements requested through HOD

Core Technical Delivery

Technical Competencies required to perform this aspect of the role:

Good understanding and experience in Excel and Access programs (Microsoft office)

Excellent understanding and working knowledge of Vendor system

Knowledge of internal audit process

Aware of external pharmaceutical requirements for audits

Good understanding and working knowledge of Quality Operations and systems.

Knowledge of pharmaceutical industry standards and guidelines in GMP and Quality

Documentation Management

Environmental, Health & Safety

Technical Report Writing

Metric Development & Report Writing

Standard Operating Procedures

Quality Management

Building own cGMP Knowledge and Compliance

Participate in building quality objectives

Participate in building a sustainable Quality Culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.

Ensuring audit readiness within role through closing out audit findings timeously

Ensure Deviations, Change Controls, CAPAs are managed effectively

Advocate continuous improvement

Technical Competencies required to perform this aspect of the role:

cGMP Knowledge

Total Quality Management & Quality Management Systems

Data development, trending & reporting

Application Deadline: 3 August 2026

If you do not receive a response from us within three weeks after closing date, 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.’’