Recipe Author (Italian speaking)

ADR Application Development Resources, Inc.; Ancona; Remoto; EUR 10.000 - 30.000; Tempo pieno

Descrizione del lavoro

A leading consulting firm is looking for a Freelance Contract Consultant with expertise in pharmaceutical manufacturing processes, particularly in electronic batch records. This remote role requires proficiency in English and Italian and offers competitive hourly compensation for specialized skills in validation and process mapping.

Competenze

• Fluency in English and Italian required.
• Expertise in EBRs and regulatory requirements essential.
• Relevant experience in pharmaceutical industry preferred.

Mansioni

• Turn paper batch records into electronic batch records (EBRs).
• Participate in process modeling and standardization.
• Provide support during HyperCare and Go-live phases.

Conoscenze

Understanding of pharmaceutical manufacturing processes

Expertise in Good Documentation Practices

Ability to process map site requirements

Experience with Microsoft Visio or similar software

Ability to author validation documents

Work in a fast-paced agile team environment

Strumenti

Rockwell Pharmasuite

P2C2

PMX

Descrizione del lavoro

Location : Remote, Italy or surrounding counties

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]