4 annunci per il ruolo di system & implementation specialist - milano, lom (recruiting in corso)

Manufacturing Process Expert
Thermo Fisher Scientific —Monza, Lombardia
- Tempo pieno
- Gestionale
- Inglese
- Produzione
1 giorno
IT Support Engineer - End-User & Workstation Services | Space Sector
Etinars —Milano, Lombardia
- Remoto
- Inglese
- Windows
Candidatura rapida
Mechanical AIT Engineer
SSC – Swedish Space Corporation —Milano, Lombardia
- CAD
- Ingegneria
- Inglese
Electrical AIT Engineer
SSC – Swedish Space Corporation —Milano, Lombardia

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For this role, candidates living far from the work location must be willing to relocate to the area of our client’s office in Italy (Rome), unless they are able…
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Manufacturing Process Expert

Thermo Fisher Scientific -
Monza, Lombardia

Candidati adesso

Dettagli della posizione

Tempo pieno
1 giorno fa

Qualifiche

Biologia
Gestionale
Inglese
Chimica
Produzione
Italiano
Audit interni

Descrizione completa della posizione

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

MAIN SCOPE OF THE POSITION/ RESPONSIBILITIES:

The Manufacturing Process Expert will serve as an advanced root cause analysis expert in support of a cross-functional team that is focused on problem-solving and continuous improvement for the site. The investigation team is a key part of the Technical Unit organization. It is focused on driving quality excellence, prevention of error and deviations, continuous improvement, and effective problem-solving. The Manufacturing Process Expert is responsible for facilitating and performing advanced root cause analysis to solve complicated technical problems and completed investigation.

ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES:

Investigations
- Management of deviations, in collaborations with cross functional team
- Investigation plan definition
- Guide and/or execute the Root Cause Analysis for deviation events and guide the definition of CAPA with cross functional team
- Execute Technical Analysis inside and outside the Technical Unit
- Coordinate a cross functional investigation team inside and outside the Technical Unit i
- Utilizes manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
Technical process knowledge
- Supports Manufacturing in the implementation of Corrective and Preventive actions (CAPA) in collaboration with Quality Specialist (QS).
- Proactively identify and mitigate risks.
- Sharing of lessons learned during the Technical Unit huddles
Audit
- Utilizes manufacturing process knowledge and investigation skills during client and Regulatory audit for the deviation assigned
Methodology/KPI
- Contribute to achieving "zero past due" objectives in Quality (CAPA, Deviations) within one's scope of responsibility, as well as RFT (Right First Time) and OTIF (On-Time In Full) objectives for document submission to the client and lot release.

RELATIONS:

Internal

All functions and seniority levels including Site Leadership Team
Supervisor Quality Manufacturing
TU assigned employees (operators, lead, team leaders, SPVs, tech team)
Quality Function

External

Corporate functions
Employees from other Thermo Fisher Scientific sites
Customers
Consulting firms
Suppliers

REQUIREMENTS

Degree in Chemistry/ CTF/ Biological Sciences or similar fields

Desirable

Experience in Quality Assurance Operations teams, with a focus on deviation management and support to GMP manufacturing Excellent knowledge of GMP and national/international regulations

Technical competences:

Necessary

Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously.
Strong interpersonal and communications skills; written and oral.
Good knowledge of cGMP.
Must be skilled in meetings and interviews to eliciting technical details from subject matter experts.
Must be skilled in the use of a personal computer and related software applications, Trackwise strongly desired.
Ability to write, handle and review GMP documentation (Deviations, CAPAs…) and understanding of main quality indicators
Knowledge of injectable sterile process manufacturing

Desirable

Solid understanding of root cause analysis tools, TapRoot preferred.
Strong planning, organization and multitasking skills.
Good knowledge of TrackWise system

Professional Experience:

Necessary (esempi)

Experience within manufacturing industries
Fluency in English and Italian

Candidati adesso

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system & implementation specialist offerte - milano, lom

Manufacturing Process Expert

IT Support Engineer - End-User & Workstation Services | Space Sector

Mechanical AIT Engineer

Electrical AIT Engineer

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