Validation Expert

Novartis ACC; Saluggia; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Italy is seeking a Validation Expert responsible for executing and managing validation activities in compliance with cGMP requirements. You will support validation planning, author protocols and reports, and ensure all validation activities adhere to regulatory standards. The ideal candidate holds a scientific degree and has previous experience in a sterile GMP environment, with fluency in Italian and English. Join us to make a difference in patients' lives.

Competenze

• Previous experience in a similar role within a sterile GMP environment.

Mansioni

• Support site validation planning by writing and maintaining master plans.
• Author and review validation protocols & reports.
• Ensure that all Site validation activities are compliant with cGMP.

Conoscenze

Fluent in Italian

Fluent in English

Knowledge of Quality and IT tools

Formazione

Scientific Degree (CTF/Pharmacy/Biotechnology/Chemical Engineering or related field)

Descrizione del lavoro

Summary

The Validation Expert is responsible for executing and managing process, primary packaging and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory exceptions.

Responsibilities

• Support site validation planning by writing and maintaining master plans for processes, cleaning, packaging.
• Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing.
• Author and review process, packaging or cleaning validation protocols & reports, ongoing process and cleaning verification protocols & reports.
• Support execution of validation activities at the shop floor.
• Reviews Master Batch Records and associated change controls. Confirm revalidation need based on technical changes.
• Provides technical expertise (and may facilitate) pre‑validation risk assessments using risk management tools.
• Work collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented.
• Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence.
• Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready.
• Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).

Qualifications

• Scientific Degree (CTF/Pharmacy/Biotechnology/Chemical Engineering or related field).
• Previous experience in a similar role within a sterile GMP environment.
• Knowledge of Quality and IT tools.
• Fluent in Italian and English.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

https://www.novartis.com/about/strategy/people-and-culture

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Benefits and Rewards

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards