Recipe Author

Buscojobs; Lazio; Remoto; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading consultancy is seeking a Recipe Author with a pharmaceutical background to work remotely, visiting customer sites occasionally. The role involves expertise in manufacturing processes, documentation practices, and agile collaboration, offering a dynamic and fulfilling work environment.

Competenze

• Understanding of pharmaceutical manufacturing processes, specifically solid oral dose and packaging.
• Experience with Good Documentation and Good Testing Practices.
• Proficient in authoring requirements and validation documents.

Mansioni

• Participate in fit-gap analysis and process modeling with Process SMEs.
• Author and support validation documents for electronic batch records (EBRs).
• Provide HyperCare and go-live support.

Conoscenze

Pharmaceutical manufacturing processes

Good Documentation Practices

Good Testing Practices

Process mapping

Validation documents authoring

Agile team collaboration

Strumenti

Microsoft Visio

Rockwell Pharmasuite

Descrizione del lavoro

Our client, a leading consultancy, is looking for a Recipe Author with a background in the Pharmaceutical sector and experience working on a Manufacturing System. The role is available remotely with travel to the customer site once or twice a month. Proficiency in Italian is required.

Requirements :

• Understanding of pharmaceutical manufacturing processes (Solid oral dose and packaging preferred)
• Expertise in Good Documentation and Good Testing Practices
• Ability to process map site requirements using Microsoft Visio or similar software
• Experience working with site SMEs to convert paper batch records into EBRs in Rockwell Pharmasuite using existing functionalities
• Experience converting existing EBRs in legacy systems (P2C2, PMX, etc.) into Rockwell Pharmasuite EBRs
• Ability to design Building Blocks for reuse across multiple processes
• Proficiency in authoring requirements, specifications, and validation documents
• Ability to test EBR full functionality in a compliant manner
• Capability to work in a fast-paced, agile team environment

Roles & Responsibilities

• Participate in fit-gap analysis, process modeling, and standardization with Area lead & Process SME
• Collaborate with lead RA to develop Building Block requirements
• Provide time estimates, user story points, and status updates for assigned stories
• Author and support validation documents for EBRs
• Configure EBRs in Development, Stage, & Production environments
• Address site-specific questions, use cases, and ERs from Site EBR and PO
• Coordinate with teams to develop requirements for ER development
• Provide HyperCare and go-live support