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.
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