Commercial Quality Sr. Analyst Fixed Term (1 year)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Job Summary

The role is responsible for ensuring compliance with temperature control qualification and validation requirements across commercial quality and warehouse operations. The position acts as a Subject Matter Expert (SME) in temperature control and as a focal point for equipment qualification computerized systems validation and regulatory applicability assessments.

Key Responsibilities

Act as Subject Matter Expert (SME) for Temperature Control ensuring compliance with RDC 430 including thermal qualifications of equipment areas and transportation providers.

Lead and execute supplier qualification activities including technical evaluation audits followup actions and documentation.

Serve as Focal Point for Computerized Systems Validation (CSV) ensuring systems meet regulatory and corporate requirements.

Perform regulatory applicability analyses for Warehouse (WH) operations including Assessment of Regulatory Requirements (ARR) and definition of mitigation actions.

Act as Focal Point for equipment qualification and thermal studies coordinating qualification strategies execution and lifecycle management.

Support inspections and audits by regulatory authorities customers and internal stakeholders related to temperature control validation and qualification.

Qualifications & Experience

Bachelors degree in Pharmacy Engineering Life Sciences or related field.

Solid experience in Quality Validation or Temperature Control within pharmaceutical biotech or healthcare environments.

Strong knowledge of RDC 430 good distribution practices and temperaturecontrolled supply chains.

Experience with equipment qualification thermal mapping CSV and supplier qualification.

Ability to act independently as an SME and crossfunctional focal point.

Strong analytical communication and stakeholdermanagement skills.

Languages

English: Advanced / Fluent

Portuguese: Fluent

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