QA Batch Record and Change Control

CAI Overview:

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field tested processes, and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do:

·       We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At CAI, we are committed to living our Foundational Principles, both professionally and personally:

·       We act with integrity

·       We serve each other

·       We serve society

·       We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing

expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done. Key Responsibilities:

• Scrittura, revisione e gestione dei Master Batch Record.
• Supporto al progetto di transizione da Batch Record cartaceo a Electronic Batch Record (eBR).
• Emissione, gestione e follow-up dei Change Control, coordinandosi con le diverse funzioni aziendali (Produzione, QA, Engineering, Validation, ecc.).
• Supporto alle attività di compliance documentale secondo GMP.

• 2–3 anni di esperienza in contesto farmaceutico GMP.
• Esperienza nella gestione documentale di produzione e/o Change Control.
• Buona conoscenza delle normative GMP.
• Ottima conoscenza della lingua inglese (scritta e parlata).

Buone capacità relazionali e di lavoro in team.