On-site monitoring of medium-complexity projects, ensuring regulatory compliance and process reproducibility in accordance with current Good Manufacturing Practices and applicable standards, identifying opportunities and proposing relevant process improvements.
Preparation, update and management of approvals for documentation involved in validation processes (AR, Protocol, Report, Matrix), as well as for procedures and plans.
Participation in production scheduling meetings to ensure validation follow-up across processes.
Management and organization of tasks assigned to interns.
Assist in gathering information for the execution of protocols and reports.
Support junior analysts and interns in meetings discussing deviations related to validation processes.
Review documentation related to validation processes.
Management, execution and logging of activities in the SE SUITE system.
Responsible for analysis and action plans for deviations related to validation.
Support and participation in internal audits, regulatory authority audits and client audits.

Experience in Process Validation.
Knowledge of Good Manufacturing Practices (GMP), regulations, standards and guidance related to validation processes.
Statistical Process Control (SPC) and quality tools.
Proficiency with MS Office applications.
Knowledge of cleaning validation processes.

Medical and dental insurance
Aché and Biosintética medications provided at no cost to employees and their direct dependents
Preventive exams without co-payment
On-site medical consultations and sample collection*
Wellhub (formerly Gympass)
"Estar Bem Aché" is our integrated health program, designed to care for the mental, physical, social, financial, occupational and intellectual well-being of employees and their legal dependents
Support programs for pregnant and postpartum female employees and their spouses
Partnerships and agreements offering scholarships and educational discounts at various institutions
Profit-sharing/Performance Participation Program (PPR)
Private pension plan (1:1 match)
On-site cafeteria and meal allowance
Transportation voucher, parking, or company shuttle*
Childcare subsidy or on-site daycare at the Guarulhos facility
Short Friday exclusive to the Guarulhos unit for administrative positions
Holiday (Christmas) gift

Mid-level Quality Assurance Analyst – Process Validation

About this role