Commercial Quality Sr. Analyst - Fixed Term (1 Year)

Johnson & Johnson UK

São José dos Campos, São Paulo, Brazil
Temperature control compliance
Equipment qualification
Computerized systems validation
The role is responsible for ensuring compliance with temperature control, qualification, and validation requirements across commercial quality and warehouse operations

Job Summary

  • The role is responsible for ensuring compliance with temperature control, qualification, and validation requirements across commercial quality and warehouse operations.
  • Act as Subject Matter Expert (SME) for Temperature Control, ensuring compliance with RDC 430, including thermal qualifications of equipment, areas, and transportation providers.
  • Support inspections and audits by regulatory authorities, customers, and internal stakeholders related to temperature control, validation, and qualification.

Matching Summary

The role is responsible for ensuring compliance with temperature control, qualification, and validation requirements across commercial quality and warehouse operations.

Skills & Requirements

Must-have

  • Temperature control compliance
  • Equipment qualification
  • Computerized systems validation
  • Regulatory applicability assessments
  • Supplier qualification activities

Nice-to-have

  • Profoundly impact health for humanity
  • Inclusive work environment
  • Respect diversity and dignity

Key Requirements

  • Bachelor’s degree in Pharmacy, Engineering, Life Sciences, or related field
  • Solid experience in Quality, Validation, or Temperature Control
  • Strong knowledge of RDC 430
  • Experience with equipment qualification, thermal mapping, CSV, and supplier qualification
  • Ability to act independently as an SME

Work Rights

Not specified

Tailored Resume

Cover Letter