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Job Description

*Previa verifica dei requisiti professionali, costituisce titolo preferenziale l’appartenenza alle Categorie Protette ai sensi dell’art 1 L. 68/99 e/o alle categorie di lavoratori che risultino percettori di interventi a sostegno del reddito e/o risultino disoccupati a seguito di procedure di licenziamento collettivo* *e/o lavoratori delle aziende del territorio di riferimento coinvolte da tavoli di crisi attivi presso il MIMIT.*

*OBJECTIVES/PURPOSE* :
- Authors, issues, and maintains PPQ protocols, PPQ reports, and supporting validation studies (eg. Mixing, process and hold times, lifecycle qualification) in alignment with internal procedures and regulatory expectations.




- Defines and supports process validation strategies across lifecycle stages, including qualification rationale, study design, and acceptance criteria.
- Supports evaluation of process changes impact, deviations, and improvement initiatives on validation status and continued process verification.
- Supports Compliance and Regulatory affairs department during preparation and update of regulatory documentation (as far as it is within its competence)
- Supports inspection readiness and contributes to internal/external audits and regulatory documentation, as applicable

*ACCOUNTABILITIES* :
- Authors, revises, and issues PPQ protocols, PPQ reports, and supporting validation studies (e.g., mixing studies, hold time studies, lifecycle qualification documents).
- Contribute to validation strategies definition and study approaches based on process knowledge, product requirements, quality risk management, and regulatory expectations.
- Establishes

📌 Process Scientist (Rieti)
🏢 Takeda Pharmaceuticals
📍 Rieti