About the role

  • QA Expert managing quality assurance processes within manufacturing operations for a global leader in pain management. Focusing on compliance with GMP standards and process improvements in Ecuador.

Responsibilities

  • Manage deviations, OOS, and reprocessing/rework, ensuring their analysis, documentation, and closure in accordance with GMP.
  • Administer and keeping the risk analysis system and the full CAPA cycle up to date.
  • Investigate quality complaints and coordinating actions with the involved areas until resolution.
  • Participate in internal audits and inspections, driving the fulfillment of corrective and preventive actions.
  • Contribute to Quality Committees through the presentation of KPIs and relevant findings.
  • Providing GMP training and onboarding to personnel to strengthen the quality culture within the plant.

Requirements

  • Degree in Pharmaceutical Chemistry, Chemistry, Chemical Engineering, or related fields.
  • More than three years of experience in activities related to production or quality within the Pharmaceutical Industry or similar sectors.
  • Strong analytical skills, critical thinking, and a focus on continuous improvement.
  • Solid communication skills with the ability to influence, persuade, and build alignment with operational, technical areas, and suppliers.
  • Strong knowledge of GMP and quality systems.
  • Organization, time management, and strong attention to documentation accuracy.

Benefits

  • Health insurance
  • Professional development opportunities

Job title

QA Expert

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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