Recipe Author (Europe or Italy)

JR Italy; Parma; Remoto; USD 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading consultancy firm is seeking a Recipe Author for a freelance contract role. This position demands expertise in pharmaceutical manufacturing processes, requiring fluency in both English and Italian. The chosen candidate will engage in the development and validation of electronic batch records (EBRs) utilizing Rockwell Pharmasuite. Successful applicants will articulate document requirements within an agile environment, ensuring compliance throughout the process.

Competenze

• Fluency in English and Italian required.
• Expertise in pharmaceutical manufacturing processes preferred.
• Experience in documentation and validation processes essential.

Mansioni

• Understand pharmaceutical manufacturing processes and translate paper records into EBRs.
• Work with site SMEs to ensure compliance in documentation and functionality of EBRs.
• Participate in process modeling and standardization with area leads.

Conoscenze

Good Documentation Practices

Good Testing Practices

Process Mapping

Agile Teamwork

Strumenti

Microsoft Visio

Rockwell Pharmasuite

Descrizione del lavoro

Social network you want to login/join with:

ADR Application Development Resources, Inc.

Location:

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

896182666188029952337114

Job Views:

2

Posted:

03.06.2025

Expiry Date:

18.07.2025

col-wide

Job Description:

Title: Recipe Author (Europe or Italy)

Location: Remote, Europe/India

This is a Freelance Contract Consultant job and will be paid in US dollars

There are 3 openings and I need one person who Speaks English and Italian

Please send CV in English

Job Description:

• 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

• 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

If you are interested in this position, please send your CV in English to me immediately at

or Call me on my What's app # [phone]