Overview
On Site
$100,000 - $120,000
Full Time
Skills
PharmaSuite
Pharmaceutics
RockWell MES
Agile
Documentation
Estimating
Fit/gap Analysis
Legacy Systems
Manufacturing
Mentorship
Microsoft Visio
Process Modeling
Quick Learner
Regulatory Affairs
Testing
Use Cases
User Stories
Job Details
Job Description
Must Have Technical/Functional Skills
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 lead RA 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
Generic Managerial Skills, If any
Resource should be quick learner and self-driven; capable of working with client partners to meet strategic Objectives
Resource must be able to identify, mentor and hone talent to build leaders from within a team.
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