Process Manufacturing Expert

2 giorni fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

**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.
- 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

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