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 wi

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