Mar 17, 2022

Job Description

1,100 associates are working globally in 12 Countries. AAA is A Novartis Company and we are focused on transforming patients’ lives by leading innovation in nuclear medicine We are 1 of 4 platforms of the Novartis Oncology Bold4Cure Strategy

Your responsibilities:

Your responsibilities include, but are not limited to:

•Ensures that every batch of a drug is produced and controlled with respect to the regulations and conditions applied to the site.
• Controls that, in the case of medicinal which come from countries not in the European union, each imported lot is subject to a semi-quantitative analysis. Decides upon any other testing necessary to guarantee the quality of the special medicine according to the conditions required for the authorization for the sale of the pharmaceutical.
• Guarantees on appropriate documents that the operations were performed as documented.
• Is responsible for the archiving of the documents according to the internal procedure and is obligated to show them on request by the health authority.
• Immediately communicates all irregularities related to the product to the competent health authorities and to the quality site/country head.
• Active collaborate in competent authorities’ inspections and performs the operations resulting from these inspections.
• Remains vigilant on the general hygiene conditions of the areas in his command.
• Contributes to the definition of production programs and ensures the realization of quality, respecting the Good Manufacturing Practices and else regulations.
• Guarantees that the production operations are documented and is responsible for their archiving and updates
• Participate in the compliance of the local quality system to the GMPs and corporate guidelines.

What you’ll bring to the role:

· In this hands on role, you'll be responsible for batch-
release of a time-dependent product. It is essential to
have either previous experience working
as a Qualified Person (QP), or have relevant
pharmaceutical qualification and 12 months experience
working in a GMP environment.

· At least two years experience working in Quality

· The ability to work in a team with excellent
communication skills

· A can-do problem solving approach

· Flexibility

·Passion for Quality Assurance

Why Advanced Accelerator Applications (AAA)

Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), 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!

Diversity & Inclusion / EEO

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

Minimum Requirements

·This role involves batch release, must be a qualified
· 12 months previous work experience in a GMP
· 2 years minimum experience in Quality Assurance
· Fluent English and Spanish both written and Oral
· This location has minimal public transport. Successful
candidates must have access to their own vehicle and
have a valid drivers license or live close-by.

Imagine what you could do at AAA!

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
Full Time
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Quality Assurance Specialist / Qualified Person (QP)

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