Our Client requires a Senior Quality Assurance Officer to contribute to its mission of establishing and maintaining effective value creation for its biological and vaccine partners and stakeholders within its current and future commercial footprint.

Summary of Role
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. • Ensure that the activities in the Quality Assurance Department are achieved at the required quality levels (SA GMP, PIC/s and WHO). • Participating in project teams and supporting other relevant organizational departments. • Continuously support and prescribe to cGMP within the Organization. Ensure compliance to all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining way of working. • Coach and provide QA leadership to QA Officers in their 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 deviations, discrepancies, root cause investigations or test failures as required. • Support allocated operational production areas of responsibility in closure of deviations, change controls, CAPAs and investigations. • Review and approve minor and major deviations and escalate critical deviations to section head and/or manager. Ensure QA browsing is conducted by QA Officers in areas of responsibility on a monthly basis and ensure that observations are documented and followed up. • Participate in weekly SAG/UAG meetings to evaluate EM and utility trends • Analyse and write annual trend reports where applicable. • Assist in product quality reviews when required. • Conduct Quality Forum meetings together with QA officer within area(s) of responsibility. Participate in projects as and when required. • Building own cGMP knowledge and compliance • Participate in achieving the company’s 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 own role through closing out audit findings timeously.

KNOWLEDGE & CAPABILITY REQUIREMENTS (Preferred)
Knowledge of Pharmaceutical related legislation. • Experience in having faced successfully local and/ or international quality audits. • Experience in aseptic (sterile) manufacturing.

REQUIRED
At least 5 years’ experience in Quality Assurance within the pharmaceutical/ biotech manufacturing industry. • Experience in quality management systems within a cGMP facility. • At least 3 years’ experience in Production 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.

REQUIRED QUALIFICATIONS
Degree or Diploma in Biotechnology, Pharmacy, Biological Sciences or a similar field • Recognition is given to Prior Learning and practical experience.

OTHER REQUIREMENTS
Potential shift work, reliable transport, ability to conduct road and air travel