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:

• 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

• Lead cross functional investigation team inside and outside the Technical Unit

• Utilizes manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and drive continuous improvement in process operations

• Technical process Knowldgment/Production

• 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 (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

• 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

• Fluency in English and Italian

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.