Description
q Understanding of pharmaceutical manufacturing processes (Solid oral dose and packaging preferred)
q Possesses expertise in Good Documentation and Good Testing Practices
q Ability to process map site requirements using Microsoft Visio or alike software
q Ability to work with site SMEs to turn paper batch records into EBRs in Rockwell Pharmasuite utilizing existing functionality
q Ability to work with site SMEs to turn existing EBRs in legacy systems (P2C2, PMX, etc.) into Rockwell Pharmasuite EBRs utilizing existing functionality
q Ability to design Building Blocks that can be reused in multiple processes
q Ability to author requirements, SPEC, and validation documents
q Ability to test an EBR full functionality in a compliant manner
q Ability to work in a fast paced agile team environment
Roles & Responsibilities
q Participates in fit gap analysis & Process Modeling & process standardization with Area lead & Process SME
q Works with lead RA to develop BB requirements
q Provide times, user story point estimates, and status for all stories assigned to them
q Authors and performs documents supporting validation of EBRs
q Configures EBR in Development, Stage, & Production Environment
q Address Site specific questions, use cases and ER from Site EBR and PO
q Works across the teams to put requirement together for ER development
q Provide HyperCare and Go-live support
q Possesses expertise in Good Documentation and Good Testing Practices
q Ability to process map site requirements using Microsoft Visio or alike software
q Ability to work with site SMEs to turn paper batch records into EBRs in Rockwell Pharmasuite utilizing existing functionality
q Ability to work with site SMEs to turn existing EBRs in legacy systems (P2C2, PMX, etc.) into Rockwell Pharmasuite EBRs utilizing existing functionality
q Ability to design Building Blocks that can be reused in multiple processes
q Ability to author requirements, SPEC, and validation documents
q Ability to test an EBR full functionality in a compliant manner
q Ability to work in a fast paced agile team environment
Roles & Responsibilities
q Participates in fit gap analysis & Process Modeling & process standardization with Area lead & Process SME
q Works with lead RA to develop BB requirements
q Provide times, user story point estimates, and status for all stories assigned to them
q Authors and performs documents supporting validation of EBRs
q Configures EBR in Development, Stage, & Production Environment
q Address Site specific questions, use cases and ER from Site EBR and PO
q Works across the teams to put requirement together for ER development
q Provide HyperCare and Go-live support