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