Process Manufacturing Expert Monza

Process Manufacturing Expert
Monza
Lombardia, Monza

Work Schedule

Standard (Mon-Fri)

**Environmental Conditions

Office

**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**:

**Experience within manufacturing industries**:

**Fluency in English and Italian**: