Hybrid Mid-level Quality Assurance Analyst – Process Validation

Posted 4 hours ago

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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

Job title

Mid-level Quality Assurance Analyst – Process Validation

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

No Education Requirement

Location requirements

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