About this role
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
• Experience within manufacturing industries
• Fluency in English and Italian