Overview
QASME Jobs in Port Elizabeth, Eastern Cape, South Africa at Aspen Pharma Group
Title: QASME
Company: Aspen Pharma Group
Location: Port Elizabeth, Eastern Cape, South Africa
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.
- 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.
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