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Quality Assurance Manager – Pharmaceutical Industry

Empresa Confidencial · Province de Buenos Aires

Senior 🇬🇧 English
GMP GDP Quality Management System CAPA Change Control Risk Assessment Audit Regulatory Inspection Quality Control

Descripcion del puesto

About the role

We are looking for a Quality Assurance Manager to lead our quality systems in the pharmaceutical sector. The role ensures compliance with local regulations, GMP/GDP standards, and corporate procedures while supporting product release and continuous improvement.

Key responsibilities

  • Maintain compliance with the Quality Management System, local regulations, GMP/GDP, and corporate policies.
  • Manage deviations, CAPAs, change controls, complaints, and risk assessments.
  • Review and approve quality documentation and support product release activities.
  • Oversee Quality Control processes and assist laboratory investigations.
  • Lead internal, supplier, and partner audits as well as regulatory inspections.
  • Drive continuous improvement initiatives, monitor quality metrics, and strengthen quality systems.

Required profile

  • Degree in Pharmacy.
  • Specialization or additional training in Quality Management Systems, GMP, or Regulatory Affairs (preferred).
  • 5–8 years of experience in Quality Assurance within the pharmaceutical industry.
  • Experience with GMP Quality Systems, Quality Control operations support, and product release.
  • Intermediate level of English.

Required skills

  • Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) knowledge.
  • Quality Management System (QMS) implementation.
  • CAPA, change control, and risk assessment processes.
  • Audit planning and execution.
  • Regulatory inspection readiness.
  • Quality Control laboratory support.

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Empresa Confidencial

Province de Buenos Aires