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:
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Investigations
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Management of deviations, in collaborations with cross functional team
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Investigation plan definition
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Guide and/or execute the Root Cause Analysis for deviation events and guide the definition of CAPA with cross functional team
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Execute Technical Analysis inside and outside the Technical Unit
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Coordinate a cross functional investigation team inside and outside the Technical Unit i
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Utilizes manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
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Technical process knowledge
- Supports Manufacturing in the implementation of Corrective and Preventive actions (CAPA) in collaboration with Quality Specialist (QS).
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Proactively identify and mitigate risks.
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Sharing of lessons learned during the Technical Unit huddles
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Audit
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Utilizes manufacturing process knowledge and investigation skills during client and Regulatory audit for the deviation assigned
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Methodology/KPI
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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
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All functions and seniority levels including Site Leadership Team
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Supervisor Quality Manufacturing
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TU assigned employees (operators, lead, team leaders, SPVs, tech team)
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Quality Function
External
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Corporate functions
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Employees from other Thermo Fisher Scientific sites
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Customers
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Consulting firms
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Suppliers
REQUIREMENTS
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Degree in Chemistry/ CTF/ Biological Sciences or similar fields
Desirable
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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.
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Strong interpersonal and communications skills; written and oral.
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Good knowledge of cGMP.
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Must be skilled in meetings and interviews to eliciting technical details from subject matter experts.
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Must be skilled in the use of a personal computer and related software applications, Trackwise strongly desired.
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Ability to write, handle and review GMP documentation (Deviations, CAPAs…) and understanding of main quality indicators
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Knowledge of injectable sterile process manufacturing
Desirable
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Solid understanding of root cause analysis tools, TapRoot preferred.
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Strong planning, organization and multitasking skills.
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Good knowledge of TrackWise system
Professional Experience:
Necessary (esempi)
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Experience within manufacturing industries
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Fluency in English and Italian
