Role/Job Title: MES Recipe Author
Work Location: Newbridge, Ireland
Mode of Working: Office based
Any other working conditions (travel/on call/shifts): Travel to sites in Ireland based on requirementThe Role MES Recipe Author for pharmaceutical manufacturing processes (Solid oral dose and packaging preferred)Your responsibilities: (Up to 10, Avoid repetition) Execution and coordination of responsibilities that include Master Recipe creation, master data creation, maintenance and control of MES activities (Recipe and workflow designer, PMC, PEC, PRC and Data manager Clients).
Process mapping (visio), Recipe designing, Testing, Dry runs and Business verification of the created recipes.
Understanding of pharmaceutical manufacturing processes (Solid oral dose and packaging preferred)
Possesses expertise in Good Documentation and Good Testing Practices
Building, Testing and verifying of recipes which require Integration (SAP, gLIMS, catalyst etc).
Coordination with core and site teams for new site-specific requirements.
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 work in a fact paced agile team environment
Preparing and conducting UAT, Change management, Validation Documentation, User trainingYour ProfileEssential skills/knowledge/experience: (Up to 10, Avoid repetition) Expert in PharmaSuite and specific functionalities.
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
Experience: 9+ YearsIf you want, I can also create a standard submission format template
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