Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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 and completed investigation.
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
- Coordinate a cross functional investigation team inside and outside the Technical Unit i
- Utilizes manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
- Technical process knowledge
- 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
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