QUALIFICATIONS NEEDED?
Degree or Diploma in Microbiology / Biotechnology, Pharmacy or equivalentNECESSARY EXPERIENCE & INDUSTRY ACCREDITATION / KNOWLEDGE?
At least 5 years' experience in Quality Assurance within the pharmaceutical/ biotech/APImanufacturing industry Sound technical ability in the field of operational Quality Assurance?
Experience in Quality Management Systems within a sterile manufacturing cGMP facility?
Quality and Regulatory compliance knowledge, i.e.
SA GMP, PIC/S and WHO as well as application.Project management in Quality Assurance?
Sound application of Risk Management and technical report writing?
Understanding of Validation & Qualification principles, Quality by design principlesKEY DUTIES & RESPONSIBILITIES OF THE ROLE• Review and approve minor and major deviations and escalate critical deviations to the manager• Review and approve CAPA in order to meet compliance requirements• Review and approve minor and major change controls for quality and regulatory compliance impactand determine requirements for implementation• Coordinate and participate in risk assessments and ensure mitigations are efficacious whenapplicable• Review and approve SOPs and Work instructions for responsible areas• Review, approval and sign-off all operational documents and records, e.g.
periodic re-qualification,periodic-revalidation including both Protocols and Reports to ensure compliance with siteapproaches, cGMP and regulatory agency requirements• Act as a QA lead on critical deviations, investigations, Risk assessments and Root cause Analysis asrequired• Ensure that the activities in the Quality Assurance Department are achieved at the required qualitylevels (SA GMP, PIC/s and WHO).
Analyse and write annual trend reports where applicable.• Support Quality Assurance with customer audits, Regulatory audits and other 3rd party audits;perform internal and supplier audits and compile audit reports; assist HOD and Manager on followup and close out of audit findings timeously.• Ensure compliance to all applicable regulations and internal procedures by proactively interpretingregulatory and quality requirements and determining way of working• Participate in achieving the company's quality objectives• Participate in building a sustainable quality culture on site and proactively mitigate risks that maynegatively impact quality or escalate these appropriately• Ensuring audit readiness within own role through closing out audit findings timeously.
Participate inprojects as / when required• Ensure project deliverables delivered as per agreed timelines and quality.
Key decision maker onquality aspects of allocated projects• Ensure quality by design, risk-based approach and risk assessments conducted and mitigated whereappropriate in accordance with project timelines• Ensure Change management, Risk management are incorporated into all allocated projects
