**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

📌 Recipe Author (Pharmaceutical Mes) - Italian Speaker - Remote (Ascoli 2x Times a Month Onsite)
🏢 iBSC
📍 Ascoli Piceno