Job purpose

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

· Plan and perform Quality Assurance functions at the appropriate standards (SA GMP, PIC/S and WHO) to ensure that products are of the quality required for their intended use.

· Design, planning, implementing, maintaining, improving and actively participating in the Pharmaceutical Quality Systems

· Provide an overview of the site processes, quality standards, and collaborate with managers and staff to improve efficiencies and compliance.

· Establish a continuous improvement culture and mechanism.

· Ensure undisrupted, punctual and safe operation of staff and processes pertaining to QA and the company’s operations.

· Achieving/ maintaining of the facilities and processes in full compliance with the current regulations and guidelines, both local and international.

· Ensure that the activities in the Quality Assurance Department and it’s 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.

· Participating in project teams and supporting other relevant organizational departments.

Minimum qualification(s)

Required:

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

Preferred:

Recognition is given to Prior Learning and practical experience.

Experience & industry knowledge

Required:

- At least 5 years’ experience in vaccine/ biotech/ or pharmaceutical manufacturing industry of which at least 3 years of sterile manufacturing experience required.

- At least 2-3 years’ experience at supervisory/management level in GMP Pharmaceutical manufacturing or equivalent

- Experience in quality and regulatory compliance within a cGMP facility

- Strong knowledge of sterile manufacturing environment

- Technical understanding of Salesforce platform and eQMS systems

Preferred:

- Working knowledge of Pharmaceutical Manufacturing related legislation

- Experience in aseptic (sterile) manufacturing.

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

- Working knowledge of Salesforce platform and system design

Key Duties & Responsibilities

People Management

· Align departmental focus areas and outputs to the business’s objectives

· Conduct business, cross functional and departmental planning and execute activities within own scope of accountability.

· Adequate capacity planning and performance delivery in line with strategic, tactical and operational plans

· Role profiling, goal setting and performance management of managers and staff within the department.

· Develop and implement a knowledge management infrastructure within the department to ensure Intellectual Property is effectively maintained

· Growth, succession & retention of departmental talent.

· Accountability for own and team's personal and professional learning & development to ensure technical and leadership bench strength within the department

· Ensure accurate delegation of ongoing operational activities in the event of key staff members’ absence.

· Conduct effective employee relations in accordance with labour legislation, company policies and procedures and address any performance and conduct concerns and risks timeously.

Technical Competencies required to perform this aspect of the role:

· KPI Development

· Resource & Capacity Planning & Management

· South African Labour Legislation

· Coaching & Mentoring of peers & staff

Business Management

· Shared accountability for achieving the site’s tactical plans and mitigation of any risk to the site operation including workflow, ethics, quality, finances, regulatory compliance and other material company requirements.

· Identify and continuously present key opportunities and synergies that will improve and/ or expand the operation within own and/ or other departments.

· Lead or participate in departmental and/ or site wide projects

· Monitoring & reporting on key operations, critical numbers and key performance indicators that impacts the business’s short, medium and long term objectives.

· Participate with the site management team in proactively mitigating risks and find solutions where possible

· Effective and comprehensive costing, budgeting and expense management, taking all overlapping site activities into consideration.

Technical Competencies required to perform this aspect of the role:

· Processes Development and Review

· Intermediate proficiency in Microsoft Word, Excel, Power point and Project.

· Metric & KPI development

· Technical Report Writing

· Operational Costing & Budgeting

· Statistical Literacy

· Coaching & Mentoring of peers & staff

Core Technical Delivery

· Manage all Quality systems activities, planning to ensure that department goals are timeously obtained

· Overall responsible for all systems within the PQS (Pharmaceutical Quality systems) including Deviations, CAPAs, Change Controls, Quality Risk Management and, DocMS, Logbook management, Archiving, Trackwise Management.

· Leads and participates in all QA engagement with external third-party stakeholders where Quality systems are impacted

· Coordinate and analyse all site metrics appropriate with the PQS and drive continuous improvement.

· Implements digital solutions to Quality processes as part of continuous improvement

· Manage activities in the Document Control Centre related to providing required documentation and implementing and maintaining related documentation systems (DocMS, Archiving, SharePoint templates, Logbook management).

· Coordinate and analyse all site metrics appropriate with the PQS and drive continuous improvement.

· Lead the site management review and ensure that action plans are tracked and implemented.

· Leads and participates in all QA engagement with external third-party stakeholders where Quality systems are impacted

· Responsible for ensuring that site compliance metrics are achieved, and actively participates in driving site compliance

· Leads all audit preparation activities on site

· Review and lead all discussions around site metrics with the applicants

· Provide technical guidance to QA Systems and site team on the QMS processes

· Drive continuous improvement on site

· Responsible to keep up to date with cGMP and Guidelines. Ensure that this is updated within the site library.

· Ensures that obligations as set out in the Quality agreements are fulfilled during the QMS process

· Review and approve documentation within defined timelines as stated in SOP’s.

· Review and approve all Deviations, Change controls, Incidents, CAPAs linked to the Quality system

· Check the maintenance of the department, premises and equipment to ensure optimal operation at all times.

· Oversee customer and regulator audits and ensure tracking and closure of findings, whilst maintaining appropriate communication between Biovac and auditors.

· Ensuring that the document control activities are achieved at the required quality levels (Biovac, SAHPRA and WHO), within the agreed timeframe.

· Ensure proper management of archived documents.

· Supports the QA operations manager with key site projects

· Ensures that scientific rationales, risk assessment and reports are in place to support operations

· Leads all QA digitalisation projects

· Lead significant investigations that can impact Quality Systems

· Lead significant risk assessments in accordance with ICH Q9

· Responsible for ensuring that the eQMS (Trackwise digital) is effectively maintained, updated to latest cGMP requirements and operational to support site activities.

· Leads all audit preparation activities within the QA departments on site

· Review and lead all discussions around site metrics with the applicants

· Responsible for ensuring that the eQMS (Trackwise digital) is effectively maintained, updated to latest cGMP requirements and operational to support site activities.

· Implement system changes on Trackwise infrastructure and salesforce and drive continuous improvement of the existing modules.

· Monitor all Trackwise tickets and close based on criticality timelines

· Provides Quality data and assessment within APQRs

· Provide technical input in response to customer and regulatory inspections responses

Technical Competencies required to perform this aspect of the role:

· Excellent understanding and working knowledge of Quality Assurance systems.

· Detailed knowledge of pharmaceutical industry standards and guidelines in cGMP and Quality.

· Documentation Management.

· Statistical Trending & Data Analysis.

· Metric Development & Report Writing.

· Coaching & Mentoring of peers & staff.

· Review & Auditing Skills.

Quality Management

· Building own, team and site’s GMP Knowledge and Compliance

· Participate in building quality objectives and provide ongoing metrics that directly support the achievement of such objectives.

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

· Establish and maintain a state of control related to quality management within the department

· Ensuring that the department is audit ready through closing out audit findings timeously

· Ensure Deviations, Change Controls, CAPAs are handled effectively

· Advocate continuous improvement within own department as well as cross functionally

Technical Competencies required to perform this aspect of the role:

· cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO

· Total Quality Management & Quality Management Systems

· Data development, trending & reporting

· Coaching & mentoring peers & staff

Application closing date: 22nd March 2027

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.