334988BR
May 09, 2022
Italy

Job Description

The QC Supervisor will ensure the appropriateness of Quality Control processes for product manufactured in the facility, and that batches quality control and QC equipment validation/qualification, QC method are executed and fully compliant to cGMPs regulation, corporate and national guidelines. They will be also responsible for developing, implementing and managing the site qualifications and requalification of existing analytical equipment and cycles as well any new equipment to meet cGMP and quality requirements

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Participate in transfers and launches by aligning on the product validation approach, being the contact point for TRD and TechOps
• Involvement in QC qualification and requalification program, method development, QC technologic improvement, ensuring that all methods used in QC analysis are validated/verified according to SOPs, MA, cGMPs and Pharmacopoeias and that all quality control processes, equipment and software are validated/calibrated according to the Validation Master Plan
• Redaction and review of SOP, protocols, reports, OOS, OOE, OOT, deviations, CAPA, change controls related to the QC department, APR, stability programs
• Lead investigation of deviation, OOS/OOE/OOT regarding QC department
• Be Deputy of QC Manager in reviewing and approving the execution of the analytical activities for the batch release if needed when QC Manager is not on site

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:

• Education: Scientific degree in Pharmacy, Chemistry or Biology
• Languages: Fluent English verbally and in writing
• Experiences: 2+ years of experience in analytical laboratory, method development, qualification of HPLC, GC, TLC,ecc

Work location: Colleretto Giacosa, Ivrea

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
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
Italy
Colleretto Giacosa
Quality
Full Time
Temporary
No
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334988BR

QC Supervisor & AS&T Facilitator (Permanent role)

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