Coordenador (a) Garantia da Qualidade
Core
Maintaining and evolving the Quality Management System for pharmaceutical industry clients and regulatory requirements.
Role type
Quality Management System Coordinator
Builds
Quality Management System
Domain
Pharmaceutical industry + Quality Assurance
Deliverable
dashboards & analysis
Required skills
Quality Management System coordination, procedure and document control, CAPA management, internal and external audit planning, regulatory compliance, risk assessment, equipment calibration and qualification, supplier management, training development, quality metrics, document system management, team leadership, computerized system validation support, technical client communication
Preferred skills
None stated
Technologies
None stated
Responsibilities
Coordinate the Quality Management System technically; Elaborate, review, approve, and control procedures and documents; Manage deviations, non-conformities, CAPAs, and change controls; Plan and follow up on internal, client, and regulatory audits; Participate in regulatory and external inspections; Monitor regulatory requirements for analytical laboratories and the pharmaceutical industry; Evaluate quality risks and propose improvements; Supervise equipment calibration, maintenance, and qualification; Support supplier and service provider management; Develop training and monitor effectiveness; Create and follow up on quality indicators; Expand the use of the document management system; Orient and develop the Quality Assurance support team; Support computerized system evaluation and validation; Support system implementation; Act in technical communication with national and international clients; Ensure quality requirements are incorporated into laboratory routine by monitoring processes, investigating deviations, evaluating data traceability, verifying training execution, and following up on actions until effectiveness is proven.
