QASME (Gqeberha)
Aspen Pharma Group · Port Elizabeth, Eastern Cape
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- Provide Quality Assurance oversight across manufacturing operations to ensure compliance with GMP, regulatory requirements, quality standards and approved product requirements. Support quality systems, investigations, risk management and continuous improvement.
Requirements
- Provide QA oversight of manufacturing, packaging, storage and distribution activities.
- Ensure ongoing compliance with GMP, regulatory and company quality requirements.
- Conduct GMP walkthroughs, audits and compliance assessments.
- Lead and approve investigations, including deviations, OOS/OOT, complaints and quality incidents.
- Review and approve CAPAs and monitor their effectiveness.
- Identify and manage quality and compliance risks.
- Monitor and trend quality data to identify recurring issues and emerging risks.
- Conduct regulatory and GMP gap assessments and implement improvement plans.
- Support regulatory, customer and internal inspections and audits.
- Review and approve GMP-related change controls and assess quality and regulatory impact.
- Drive continuous improvement to strengthen compliance, reduce recurring quality issues and improve inspection readiness
Qualification
- Bachelor's Degree in Pharmacy
Experience
- 5–8 years' experience in a pharmaceutical manufacturing quality environment.
- 2–3 years' leadership experience.