Expert

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7o2hoi

Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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.

Investigations

Management of deviations, in collaborations with cross functional team Guide and/or execute the Root Cause Analysis for deviation events and guide the definition of CAPA with cross functional team Utilizes manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and drive continuous improvement in process operations Supports Manufacturing in the implementation of Corrective and Preventive actions (CAPA) in collaboration with Quality Specialist (QS). 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.

Supervisor Quality

Manufacturing TU assigned employees (operators, lead, team leaders, SPVs, tech team) Corporate functions Customers Degree in Chemistry/ CTF/ Biological Sciences or similar fields 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 Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously. Good knowledge of cGMP.

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...) Knowledge of injectable sterile process manufacturing. Solid understanding of root cause analysis tools, TapRoot preferred.

Strong planning, organization and multitasking skills. Good knowledge of TrackWise system Professional Experience: Experience within manufacturing industries Fluency in English and Italian Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7o2hoi