Quality Operations Specialist

Support functions in the Americas region on the market and distribution batch release process through review and preparation of relevant documents, and when applicable final disposition decision, in accordance to global and local regulations and processes.

Perform local operations that support product release and commercialization.

Main Acountabilities

• Review of relevant GxP documentation that support product release and packaging material release.
• Where the activity has been delegated, perform the final disposition decision on finished product and packaging material.
• Perform pre-release checks and activities that make the preparation process more agile.
• Perform local operations that support product release to the market and commercialization, such as, but not limited to: review of temperature data loggers, exception management (temperature excursions), master data management, product returns, customer clarification letters, etc.
• Workflow improvement through identification issues and reporting to the business partner.
• Hold and manage key accounts in workflow applications to ensure appropriate execution of service deliverables.
• Generate and analyze predefined and ad-hoc reports in various applications and perform follow-up actions if required.
• Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements.
• Regularly communicate with partners to collect feedbacks on support services, report deliverable and acquire process knowledge.
• Support implementing process quality improvement projects within the organization.

• Process requiring management intervention to resolve (partner escalation)

• Minimum requirements

• Bachelor's degree in Pharmacy.

• 5+ years of progressive experience in Quality Control within regulated industries (e.g., pharmaceuticals, biotech)
• Demonstrated expertise in GMP/GLP, method validation/verification, instrument qualification, and laboratory quality systems.
• Proven track record managing inspections (e.g., FDA, ANVISA, COFEPRIS, ANMAT, ISO accreditation) and driving effective CAPA
• Fluency in English or Portuguese required; trilingual (English, Portuguese) strongly preferred.
• Excellent leadership, stakeholder management, and communication skills.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation:

Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis tiene el compromiso de trabajar y proporcionar adaptaciones razonables para personas con discapacidad. Si, debido a una condición médica o discapacidad, necesita una adaptación razonable para cualquier parte del proceso de contratación, o para desempeñar las funciones esenciales de un puesto, envíe un correo electrónico a y permítanos conocer la naturaleza de su solicitud y su información de contacto. Incluya el número de posición en su mensaje.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

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Division

Operations

Business Unit

Quality

Location

Brazil

Site

Santo Amaro

Company / Legal Entity

BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No