Recipe Author

**Recipe Author (Pharmaceutical MES) - Italian Speaker - Remote (Ascoli 2x times a month onsite)**

**Job Title**: Recipe Author (MES - Pharmaceutical Manufacturing) **Location**: Remote - (**Onsite 1x OR 2x a month in ASCOLI - Italy is mandatory**) **Duration**:6-12 Months + Extension **Language Requirement**: Fluent in Italian **Rate**: €50 per hour, all inclusive

**THIS PROJECT IS OUTSIDE IR35**

**Overview**

**Key Responsibilities**
- Collaborate with on-site Subject Matter Experts (SMEs) to translate **paper-based batch records** into **MES-based EBRs**:

- Migrate Legacy EBRs from existing systems (eg, P2C2, PMX) into a new MES platform using existing functionalities
- Design **modular, reusable building blocks**for batch processes
- Create clear and compliant **process maps** using tools like **Microsoft Visio**:

- Draft and maintain **requirements, specification, and validation documentation** in line with **GMP and CSV standards**:

- Test and validate EBR functionality in a **regulated pharmaceutical environment**:

- Ensure all documentation and practices align with **Good Documentation Practices (GDP)** and **Good Testing Practices (GTP)**:

- Work within an **Agile delivery environment**, collaborating with a cross-functional team of developers, engineers, and QA professionals

**Key Requirements**
- Solid understanding of **pharmaceutical manufacturing processes**, especially solid oral dose and packaging
- Hands-on experience with **MES platforms** - strong preference for **Pharma Domain**:

- Familiarity with Legacy MES systems (eg, P2C2, PMX)
- Proven experience authoring and testing **Electronic Batch Records (EBRs)**:

- Strong grasp of **Good Documentation Practices (GDP)** and **Good Testing Practices (GTP)**:

- Experience writing **functional requirements, system specifications, and validation documents**:

- Proficient in **Microsoft Visio** (or similar process mapping tools)
- Ability to communicate effectively in **Italian** (written and spoken)
- Comfortable working in a **fast-paced Agile team** environment
- Onsite once or twice a month is mandatory in Ascoli in Italy