Manufacturing Specialist

2 weeks ago


Singapore ABBVIE Full time

Purpose Statement


To perform investigations, change plans or other functional support associated with cGMP manufacturing operations within the biologics production facility and work cross functionality.


Major Responsibilities:

  • Perform technical writing and investigation of nonconformances in collaboration with Operations including material defects
  • Identify and put in place appropriate corrective and preventative actions in collaboration with Operations team
  • Owner of change plans in collaboration with cross functional teams, including global cross functional team, if required
  • Work with Quality systems (e.g. CAPA and change plans) and Operations Related System (LIMS, SAP, PI, Maximo, MS Office)
  • Participates in continuous improvement projects for operations
  • Trends Key Performance Indicators and implement measures to streamline work processes and procedures
  • Assist in regulatory inspections
  • Works under close supervision

For more experience individual, you are required to:

  • Supports new product introduction projects and leads continuous improvement projects for operations
  • Support in regulatory inspections, detailing investigations and change plans
  • Structure training program for new hires and conduct relevant trainings
  • Works with mínimal supervision
  • Bachelor in Science or Bachelor in Engineering with at least 2 years of relevant experience
  • Experience with cGMP documentation and record maintenance
  • Strong working knowledge of GMP systems (e.g. Trackwise, SAP, LIMS, MES systems)
  • Knowledge and experience in root cause analysis and investigation
  • Strong critical thinking, problem solving and technical writing skills
  • Ability to lead crossfunctional team discussions
  • Excellent attitude towards work, with strong workload management and to drive tasks to completion
  • Experience with regulatory inspections is required
  • Good interpersonal and communication skills


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