Dec 06, 2022

Job Description

The QA Manager is in charge of the maintenance at local level of 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.

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Safeguarding of the quality of the medicinal products which have been manufactured by the radiopharmaceutical site.
• Maintain and supervise the local quality system as per GMPs and corporate guidelines.
• Perform the APR achievement according to the calendar.
• Ensure 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.
• Ensure that out of specifications, out of trend, 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).
• Assure, at local level, the execution of the staff GMP training and the respect of the training annual plan.
• Complaint management at local level and assure the application of the recall procedure in case of critical issues impacting the products as per GMPs and Health Authorities (AIFA and FDA) requirements.

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

What you’ll bring to the role:

• Degree in scientific disciplines.
• Possess the QP certification released by AIFA.
• At least 2 years’ experience within the QA department of a pharmaceutical company.
• Good knowledge of quality control and production in a GMP environment.
• Good organizational skills (time management, risk management) including attention to detail and multitasking skills.
• Fluent in Italian and English.

Work location: Meldola.

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!

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
Full Time
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QA Manager / QP - Meldola

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