Feb 28, 2024

About the Role

The Quality Assurance Engineer, is responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at the AAA radioligand manufacturing site.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Provide QA oversite for the development, qualification, validation, and transfer of analytical methods
• Contribute to the definition of project plan, control requirements and processes to deliver the new manufacturing facility on time, to required quality and compliance standards and within budget.
• Acts as the Quality approver of change controls, deviations, and CAPAs required to maintain the manufacturing facility in a GMP state.
• Work with validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility. Play a lead role in the planning, execution and closure of commissioning, qualification and validation activities from a Quality functional perspective.
• Collaborate with MS&T to ensure products are maintained in a validated stated.
• Provide strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters).

Diversity & Inclusion / EEO

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

Role Requirements

What you’ll bring to the role:

• 5+ years of experience in a GxP pharmaceutical manufacturing operations and 2+ years of experience in a quality assurance role
• Strong knowledge and experience with the application of CFRs and cGMPs and have been involved in regulatory inspections.
• Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections
• Experience participating in internal audits, identify findings, driving to resolution and providing closure report is desired.

Work location: Colleretto Giacosa.

Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Imagine what you could do at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Colleretto Giacosa
Full Time
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QA Engineer

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