Subject Matter Expert

Novartis; Torre Annunziata; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading global healthcare company in Italy is seeking a Subject Matter Expert to oversee technical solution development and maintain compliance with GMP. The ideal candidate will have a scientific or engineering degree, previous experience in GMP manufacturing, and be fluent in Italian. This full-time role requires collaboration across various stakeholders to enhance operational processes and ensure adherence to regulatory standards.

Competenze

• Previous experience in a similar role within a GMP manufacturing site.
• Able to work in a global matrix environment.

Mansioni

• Oversees the development testing and implementation of the technical solution.
• Cultivates effective working relationships with a variety of stakeholders.
• Supports continuous improvement through a risk based approach.

Conoscenze

Fluent in Italian

Good knowledge of English

Experience in system testing

Knowledge of SAP

Good Documentation Practice

Formazione

Scientific or Engineering degree

Strumenti

Databases

System Design

Cybersecurity

Descrizione del lavoro

Job Description 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 HSE GMP Regulatory and company requirements and policies.

Job Description

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.

Cultivates and maintains effective working relationships with a variety of stakeholders including end-users project managers engineers QA MS&T and senior staff members.

Supports the continuous improvement through 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.

Skills Desired

Change Control Chemical Engineering Continual Improvement Process Efficiency Employment Discrimination Flexibility General Hse Knowledge Good Documentation Practice Knowledge Of Capa Knowledge Of Gmp Lean Manufacturing Manufacturing Process Manufacturing Production Physics Process Control Production Line Productivity Risk Management Root Cause Analysis (RCA) Scheduler Technology Transfer Well-Being

Key Skills

• Databases
• System Design
• Cybersecurity
• System Architecture
• Intelligence Experience
• Military Experience
• Requirements Gathering
• Joint Operations
• Curriculum Development
• DoD Experience
• FISMA
• Ant

Employment Type : Full-Time

Experience : years

Vacancy : 1