Batch Record Creation Lead

• 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 improve performance.
  
• Collaborate with multidisciplinary teams to achieve project objectives.
  
• Assist in experimental design and troubleshooting as needed.
  

Requirements

• Bachelor's degree in a relevant life science field (biology, biotechnology, biochemistry).
  
• Previous experience in a GMP environment is preferred.
  
• Strong attention to detail, organizational skills, and the ability to work independently or in a team.
  
• Excellent communication skills, both written and verbal, in English.
  
• Adherence to safety protocols and regulatory compliance.