Subject Matter Expert

Novartis Italia; Torre Annunziata; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Torre Annunziata is seeking a Subject Matter Expert to oversee the development and implementation of technical solutions while ensuring compliance with GMP regulations. The ideal candidate has a scientific or engineering degree, experience in a GMP environment, and is fluent in Italian. Join us in making a difference in patients' lives with your expertise and innovative approaches.

Servizi

Opportunities for professional growth

Comprehensive benefits package

Competenze

• Previous experience in a similar role within a GMP manufacturing site.
• Demonstrated understanding of GMP, HSE, and regulatory requirements.

Mansioni

• Oversee the development, testing, and implementation of technical solutions.
• Review technical documentation for accuracy.
• Ensure local SOPs are aligned with company policies.
• Cultivate relationships with stakeholders.
• Support continuous improvement using risk-based approaches.
• Supervise maintenance and calibration work.

Conoscenze

Scientific or Engineering background

Experience in system testing

Fluent in Italian

Knowledge of English

SAP knowledge

Ability to work in a global matrix environment

Formazione

Scientific or Engineering degree

Descrizione del lavoro

Summary

The Subject Matter Expert understands, articulates, and implements best practices related to their area of expertise. Depending on the work environment, the subject matter expert may lead or be an active participant of a work-group with the need for specialized knowledge. The subject matter expert provides guidance on how their area of capability can resolve an organizational need, and actively participates in all phases of the system life cycle management (Design to disposal), in accordance to TPM, HSE, GMP, Regulatory and company requirements and policies.

About The Role

Major accountabilities:

• Oversees the development, testing, and implementation of the technical solution, and validates the final product satisfies the defined requirements.
• Reviews technical documentation, such as user guides, training manuals, and system specifications, prior to distribution to end-users, and ensures their subject area is accurately represented.
• Ensure that local SOPs related to his area of expertise, will be aligned to HSE, GMP, Regulatory and company requirements and policies will follow TPM approach.
• Cultivates and maintains effective working relationships with a variety of stakeholders, including end-users, project managers, engineers, QA, MS&T and senior staff members.
• Support the continuous improvement trough a risk based approach, using specific tools like FMEA/FMECA RRCI RCA, for new projects and life cycle management of existent equipment.
• Serialization and aggregation tasks.
• Supervise maintenance / calibration work as Subject Matter Expert (SME).
• Maintenance and calibration activities (preparing tools, identifying spare parts, executing work orders etc).

Essential Requirements

• Scientific or Engineering degree.
• Previous experience in a similar role within a GMP manufacturing site.
• Fluent in Italian. Good knowledge of English.
• Experience in system testing and business processes. SAP knowledge.
• Able to work in a global matrix environment.

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