Quality Assurance Engineer (Batch Record and Change Control)

ph3Overview /h3 pCAI 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. /p pOur approach is simple because our Purpose informs everything we do: /p ul liWe exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. /li /ul pAt CAI, we are committed to living our Foundational Principles, both professionally and personally: /p ul liWe act with integrity /li liWe serve each other /li liWe serve society /li liWe work for our future /li /ul pAt 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. /p h3Responsibilities /h3 ul libScrittura, revisione e gestione dei Master Batch Record. /b /li libSupporto al progetto di transizione da Batch Record cartaceo a Electronic Batch Record (eBR). /b /li libEmissione, gestione e follow-up dei Change Control, coordinandosi con le diverse funzioni aziendali (Produzione, QA, Engineering, Validation, ecc.). /b /li libSupporto alle attività di compliance documentale secondo GMP. /b /li /ul h3Qualifications /h3 ul lib2–3 anni di esperienza in contesto farmaceutico GMP. /b /li libEsperienza nella gestione documentale di produzione e/o Change Control. /b /li libBuona conoscenza delle normative GMP. /b /li libOttima conoscenza della lingua inglese (scritta e parlata). /b /li libBuone capacità relazionali e di lavoro in team. /b /li /ul h3Compensation /h3 pbThe compensation package offered ranges from €34,000 to €45,000 gross per annum (Gross Annual Salary). The final salary within this range will be determined according to the candidate’s technical competencies and relevant professional experience. /b /p pLa selezione rispetta il principio delle pari opportunità (l. 903/77) /p /p #J-18808-Ljbffr