Description

Create business process flow diagram for pharmaceutical product recipes based on the paper batch record or source documents.

• Gather MES Site specific requirement analysis to develop URS and FRS.

• Logically breakdown the recipes/Mfg. process to configure the recipe in to MES

• Develop/create EBR design elements (building blocks) and workflows in MES for repetitive use in EBR creation to expedite the process.

• Experience with EBR design for Biotech, Gene Therapy, Vaccine Manufacturing, Packaging processes in Pharma.

• Gather master data and configure in MES Development/Quality/Production Environment.

• Integrating MES with SAP and other automation systems using standard interface component of MBR design.

• Lead the recipe design session with business process SMEs.

• Design EBR/recipe, equipment workflow/ status diagram based on the Business process flow.

• Create solution design and configuration document.

• Prepare key user training documents and impart key user training.

• Provide assistance in business SOP creation.

Education

Any Gradute