Process Manufacturing Expert

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gxe4z

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **MAIN SCOPE OF THE POSITION/ RESPONSIBILITIES**:
**The Manufacturing Process Expert will serve as a sophisticated 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 teamworks with cross functional team**:
**Investigation plan definition**:
**Lead and/or complete the Root Cause Analysis for deviation events and guide the definition of CAPA with a cross-functional team**:
**Implement technical analysis within and outside the Technical Unit**:
**Lead cross functional investigation team inside and outside the Technical Unit**:
**Applies knowledge of manufacturing processes and investigation skills to identify and resolve manufacturing issues, while driving continuous improvement in process operations.**:
**Technical process Acknowledgment/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**:




**Applies manufacturing process knowledge and investigation skills when conducting client and Regulatory audits for assigned deviations.**:
**Approach/Important Metric**:
**Give 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**:
**Direct report of Quality Operations Manufacturing Supervisor**:
**Collaboration with Quality Specialist of the TU**:
**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**:
**Ability to function in a fast paced, multifaceted 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**:
**Experience within manufacturing industries**:
**Fluency in English and Italian**:

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gxe4z