Commercial Quality Sr. Analyst - Fixed Term (1 Year)
Johnson & Johnson
São José dos Campos, São Paulo, Brazil
Temperature control compliance rdc 430
Equipment qualification and thermal mapping
Computerized systems validation csv
The role serves as a Subject Matter Expert for temperature control ensuring compliance with RDC 430 across commercial quality operations
Job Summary
The role serves as a Subject Matter Expert for temperature control ensuring compliance with RDC 430 across commercial quality operations.
Candidates will lead supplier qualification activities including technical evaluations, audits, and documentation to maintain regulatory standards.
This position acts as the focal point for computerized systems validation and coordinates equipment qualification strategies within warehouse operations.
Matching Summary
The role serves as a Subject Matter Expert for temperature control ensuring compliance with RDC 430 across commercial quality operations.
Skills & Requirements
Must-have
Temperature control compliance RDC 430
Equipment qualification and thermal mapping
Computerized systems validation CSV
Supplier qualification and audits
Warehouse regulatory applicability analysis
Nice-to-have
Cross-functional stakeholder management
Continuous improvement methodologies
Strong analytical problem solving skills
Key Requirements
Bachelor's degree in Pharmacy or Engineering
Solid experience in pharmaceutical quality and validation