Hybrid Mid-level Quality Assurance Analyst – Process Validation

at Aché Laboratórios

• Job title: Mid-level Quality Assurance Analyst – Process Validation
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: No Education Requirement
• Location requirements: Hybrid, Guarulhos, Brazil

About the role

• Quality Analyst monitoring compliance and validation processes at Aché pharmaceutical company in Guarulhos. Involves project oversight, documentation management, and support during internal audits.

Responsibilities

• 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.

Requirements

• 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.

Benefits

• 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