Ftps Recipe Authors

2 settimane fa


Ascoli Piceno, Italia Siro Clinpharm Pvt Ltd A tempo pieno

**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

**Job Type**: Contract
Contract length: 12 months

Work Location: Hybrid remote in 63100 ASCOLI PICENO, AP