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 (esempi)
- Experience within manufacturing industries
- 3-5 years of previous experience in the role
- Fluency in English and Italian
- Ability to work various shifts as required
- Knowledge of root cause analysis and quality improvement tools
- Demonstrated ability to guide and develop team members
- Experience with clean room operations and gowning procedures preferred
- Ability to understand and interpret technical procedures and specifications