Senior QA Specialist

SUMMARY:
Our client is one of the leading sterile vaccine manufacturers rooted in Africa.  Their core purpose it to “protect life”.  They are looking to hire a dynamic, passionate, confident, proactive and meticulous Senior QA Specialist to join their goal-oriented team.

POSITION INFO:

QUALIFICATIONS NEEDED 

• Degree or Diploma in Microbiology / Biotechnology, Pharmacy or equivalent

• At least 5 years’ experience in Quality Assurance within the pharmaceutical/ biotech/API manufacturing 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 principles

• 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 impact and determine requirements for implementation
• Coordinate and participate in risk assessments and ensure mitigations are efficacious when applicable
• 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 site approaches, cGMP and regulatory agency requirements
• Act as a QA lead on critical deviations, investigations, Risk assessments and Root cause Analysis as required
• Ensure that the activities in the Quality Assurance Department are achieved at the required quality levels (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 follow up and close out of audit findings timeously.
• Ensure compliance to all applicable regulations and internal procedures by proactively interpreting regulatory 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 may negatively impact quality or escalate these appropriately
• Ensuring audit readiness within own role through closing out audit findings timeously. Participate in projects as / when required
• Ensure project deliverables delivered as per agreed timelines and quality. Key decision maker on quality aspects of allocated projects
• Ensure quality by design, risk-based approach and risk assessments conducted and mitigated where appropriate in accordance with project timelines
• Ensure Change management, Risk management are incorporated into all allocated projects

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