Process Manufacturing Expert (Sostituzione Monza

Process Manufacturing Expert (Sostituzione
Monza
Lombardia, Monza

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