Technical Author

Our client, a leading consultancy is looking for a Technical Author with background in the Pharmaceutical sector and experience of working on a Manufacturing System. The role is available remotely with travel to the customer site once/twice a month. You must be proficient in Italian.

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 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