344618BR
May 12, 2022
Italy

Job Description

The person is responsible for developing, implementing and managing the site qualifications and requalification of existing equipment and cycles as well any new equipment. Responsible for developing, implementing and managing process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
Responsible for scale-up cold kits by developing and completing a validation strategy according to cGxP. Carrying out and handling equipment qualifications, requalification, periodic reviews and process, primary packaging, and cleaning validation activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations

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

• Participate in transfers and launches by aligning on the product validation approach. Provide technical expertise for pre-validation / validation strategy.
• Ensure equipment is in qualified state and qualified ranges are aligned to meet process parameters.
• Establish a qualification and requalification program (IOQ and PQ) for the site and complete activities according to plan and defend to authorities.
• Perform equipment periodic reviews according to internal procedures.
• Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.
• Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV).
• Ensure equipment is qualified and manufacturing and cleaning processes are validated; overview on site state of validation is maintained.
• Support MS&T activities in ensuring that responsible departments execute and maintain the VMP activities.

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: BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology. Desirable PhD in the above or equivalent
• Languages: Fluent in English and proficient in site local language
• Experience / Professional requirements: Thorough understanding of manufacturing processes and related process equipment.
• Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
• 5 year experience in executing equipment qualifications, process validation, having led and managed validation projects, including sterile manufacturing.
• Reviewing and writing technical reports and project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).


Work location: Saluggia

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
Saluggia
Technical Operations
Full Time
Regular
No
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344618BR

Validation Expert

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