Overview
Work Schedule: Standard (Mon-Fri)
Responsibilities

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 focused on problem-solving and continuous improvement for the site. The investigation team drives quality excellence, prevention of errors and deviations, continuous improvement, and effective problem-solving. The Manufacturing Process Expert facilitates and performs advanced root cause analysis to solve complicated technical problems.
ASSIGNMENTS, SPECIFIC / PRIMARY ACTIVITIES:

Investigations: management of deviations in collaboration with cross-functional team
Investigation plan definition
Guide and/or execute 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
Utilize manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
Technical process knowledge / Production
Support Manufacturing in the implementation of Corrective and Preventive Actions (CAPA) in collaboration with Quality Specialist (QS)
Proactively identify and mitigate risks
Share lessons learned during Technical Unit huddles
Audit: participate in client and regulatory audits for the assigned deviation, using manufacturing process knowledge and investigation skills
Methodology / KPI: contribute to achieving zero past due objectives in Quality (CAPA, Deviations) and other objectives such as Right First Time (RFT) and On-Time In Full (OTIF) 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; Strong interpersonal and communications skills; Thorough knowledge of cGMP; Ability to write, handle and review GMP documentation (Deviations, CAPAs); 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: Experience within manufacturing industries
Desirable: N / A


Languages: Fluency in English and Italian

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