352967BR
Sep 22, 2022
Spain

Job Description

11! That’s the average number of batches will be released a week at Advanced Accelerator Applications, Zaragoza. 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.

As part of your continued professional development, you will receive full training in this specialist medicine. As Quality Assurance Specialist you will be in charge of the maintenance at local level of the national quality management system as per GMP regulation and corporate guidelines as well as of all health regulated activities ensuring that all the relevant external and internal requirements are implemented, monitored for performance and adherence

This role is based in La Almunia de Doña Godina, Zaragoza

Your responsibilities:
Your responsibilities include, but are not limited to:
• Participate in the compliance of the local quality
system to the GMPs and corporate guidelines
• Assure the respect of the GMPs and Health
Authorities requirements at local level
• Safeguarding of the quality of the medicinal products
which have been manufactured by the
radiopharmaceutical site
• Perform the APR achievement according to the
calendar
• Endure and manage the quality system procedures to
guarantee the respect of GMPs, National/Corporate
Guidelines and Health Authorities requirements
• Assure the correct registration and archiving of the
documentation at local level
• Assure the execution of qualification, maintenance,
calibration and revalidation programs at local level
• Act directly to the annual quality audit
• Ensure that Out of specifications, Out of trends,
deviations, CAPA, Change controls are addressed
and recorded according to cGMP and SOPs
• Participate to the self-inspections as per approved
annual plan and to the external audits (Health
Authorities, Certified Bodies, Supplier)
• Manage at local level the external inspections follow
up
• Assure, at local level, the execution of the staff GMP
training and the respect of the training annual plan
• Complaint management at local level

What you’ll bring to the role:
• Good organizational skills including attention to
details
• Knowledge of quality system (GMP)
• Basic knowledge of regulatory requirements
• Shows the appropriate sense of urgency around given
tasks
• Works collaboratively

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 ground-breaking 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

Education: Bachelor’s degree in Pharmacy, Chemistry or similar

Languages: English: fluent spoken and written

Experience:
• +2 years of experience in a Quality department
preferably for a pharmaceutical company
• Knowledge of quality system (GMP)
• Basic knowledge of regulatory requirements

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
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
Spain
Zaragoza
Quality
Full Time
Regular
No
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352967BR

QA Specialist

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