Manager-MSAT

Job Description

• Responsible for upstream manufacturing process support, data acquisition, and trending.
• To manage statistical analysis of manufacturing batches data using statistical software like Minitab, etc.
• Lead the upstream team in troubleshooting and process related deviation investigations activities to identify the root cause followed by providing an effective CAPA.
• Plan, evaluate and manage the technology transfer of new / existing products from sending unit (R&D) to receiving unit (Manufacturing).
• To collaborate and communicate regularly with R&D teams in execution of experimental runs and any other scale down experiments to support manufacturing process changes/improvements.
• Planning and successful implementation of process changes in upstream manufacturing processes with relevant CFT consensus.
• Responsible for risk assessment, validation protocols, validation reports and facility fit assessment applicable for upstream processes.
• Review of technical documents i.e. manufacturing batch records, SOPs, study protocols, study reports and cleaning validation documents etc.
• Coach, mentor and train upstream team members in skill development.

Work Experience

8 - 15 years

Education

Competencies