Subject Matter Expert

Healthcare Businesswomen’s Association; Torre Annunziata; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading healthcare organization in Torre Annunziata is seeking a Subject Matter Expert to oversee technical solutions and ensure compliance with GMP standards. The ideal candidate will have a degree in Science or Engineering, prior experience in GMP manufacturing, and be fluent in Italian. This role involves collaboration with various stakeholders and requires strong documentation and risk management skills. Competitive compensation and opportunities for professional growth are available.

Competenze

• Previous experience in a similar role within a GMP manufacturing site.
• Experience in system testing and business processes.
• Able to work in a global matrix environment.

Mansioni

• Oversee development, testing, and implementation of technical solutions.
• Review technical documentation prior to distribution.
• Support continuous improvement with a risk-based approach.

Conoscenze

Fluent in Italian

Good knowledge of English

Change Control

Lean Manufacturing

Risk Management

Root Cause Analysis (RCA)

Formazione

Scientific or Engineering degree

Strumenti

SAP

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 TPM, HSE, GMP, Regulatory and company requirements and policies.

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 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