Work Schedule

Environmental Conditions

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. 

ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES:

•    Investigations:
o    Management of deviations, in collaborations with cross functional team
o    Investigation plan definition 
o    Guide and/or execute the Root Cause Analysis for deviation events and guide the definition of CAPA with cross functional team
o    Execute Technical Analysis inside and outside the Technical Unit
o    Lead cross functional investigation team inside and outside the Technical Unit
o    Utilizes manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
•    Technical process Knowldgment/Production 
o    Supports Manufacturing in the implementation of Corrective and Preventive actions (CAPA) in collaboration with Quality Specialist (QS).
o    Proactively identify and mitigate risks. 
o    Sharing of lessons learned during the Technical Unit huddles
•    Audit
o    Utilizes manufacturing process knowledge and investigation skills during client and Regulatory audit for the deviation assigned
•    Methodology/KPI
o    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 (alcuni esempi)
•    All functions and seniority levels 
•    Direct report of Qop Manufacturing Supervisor
•    Collaboration with Quality Specialist of the TU
External (alcuni esempi qui sotto)
•    Corporate functions
•    Employees from other Thermo Fisher Scientific sites
•    Customers
•    Consulting firms
•    Suppliers

REQUIREMENTS

Education:

Necessary
•    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.
•    Thorough 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.

Professional Experience:

Necessary (esempi)
•    Experience within manufacturing industries

Desirable
•    N/A

Languages:

•    Fluency in English and Italian