QASME

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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