Job Description

Job Description

  • Lead and execute multiple Change Records (Planned events) for the assigned area for creation of new Batch Records and Standard Operation Procedures for Production
  • Support Change Records Assessment and GMP documentation Review.
  • Responsible for providing support to the assigned manufacturing operations by developing, coordinating and facilitating small to medium projects to ensure planned, predictable production operations in compliance with GMP regulations.
  • Lead and execute Continuous Process Improvements, CAPAs and Change Records in assigned area
  • Provide routine and ad hoc support for planning, coordinating, execution, and performance improvement of key manufacturing processes such as product change over.
  • Lead project teams to trouble shoot medium to complex problems and support continuous process improvement. Facilitate root cause analysis (RCA) with input from SMEs, develop and implement change to improv...

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