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 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. 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.
Responsibilities
Key responsibilities include :
* Provides knowledge and experience in validation approaches applied to systems and processes
* Manage Deviation / Change Control applied to validation studies
* Experience in process validation, cleaning validation, equipment qualification, and filter validation
* Support generation of CQV procedures for client projects
* Support CQV review / qualification of equipment design, operation, and performance qualification / verification related documents, including SOPs, validation / master plans, guidelines and execution plans
* Strong cGMP and regulatory understanding
* Interprets client needs, assesses requirements, and identifies solutions to non-standard requests
* Ensure the highest quality, compliance and safety standards
* Works collaboratively to facilitate client alignment and best practices adopted for validation
* Other : Project Management – reliably create resource-loaded schedules
* Assumes personal responsibility for specific components of larger projects and creates strategies to balance short-term requirements with long-range business plans
* Pursues meaningful initiatives to capitalize on strengths, market opportunities, and counter competitive threats
* Aligns strategic priorities of own area with current direction and strategic priorities of the broader organization
* Applies commercial insights to understand financial and economic levers that impact business performance and deploys them to improve short- and long-term results
* Focus on customers : identifies and anticipates customer requirements, expectations, and needs, and creates systems that make it easy to do business with CAI
* Lead execution : maintains accountability, delegates appropriately, and ensures resources, information, authority, empowerment, and support needed to achieve objectives
* Influence and engage others : identifies agendas and motivations, negotiates persuasively to create win-win solutions, cultivates networks, and inspires and coaches others
* Build talent : provides feedback and coaching, shapes roles, develops successors and diverse talent, and promotes recruitment and advancement of the best people
* Achieve results with people : fosters energy and ownership, inspires others to stretch, sets high standards, and rewards performance excellence
* Lead courageously and safely : develops a safe and inclusive work culture, leads with integrity, and makes tough decisions to drive breakthrough ideas and safe working processes
* Travel : available for travel domestically and internationally as required
La selezione rispetta il principio delle pari opportunità (l. 903 / 77).
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing
Availability to travel for assignments in Italy and abroad.
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