QA/Validation Engineer
CAIItaly3 days ago
Full-timeQuality Assurance
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CAI Overview:
Are You Ready?
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:
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:
Performs Batch Disposition preparation, Batch record review, Certification process oversight.
Strong cGMP and regulatory requirement understanding.
Experience In Trackwise.
Support all quality and compliance requirements for and leading to commercial manufacturing.
Uses knowledge to improve Quality Systems and/or Operational Quality with clients; solve complex problems and provide guidance and support for continuous improvement.
Understands and applies regulatory / compliance requirements to the role ensuring alignment and recommendation with current or upcoming regulatory and compliance changes.
Interprets client’s needs, assesses requirements, and identifies solutions to non-standard requests.
Ensure the highest Quality, Compliance and Safety standards
Works collaboratively to facilitate client and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality
Excellent Oral And Written English Are Required.
Suitable candidates must be available for travel throughout Italy and some European travel may be required.
La selezione rispetta il principio delle pari opportunità (l. 903/77)
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.
Apply Commercial Insights
Demonstrates understanding of financial and economic levers that impact business performance and deploys them to improve short- and long-term results.
Promotes best-in-class risk awareness and reviews risk management performance on a continuing basis.
Draws appropriate conclusions from financial reports and analyses to identify and evaluate major strategic priorities and investments.
Focus on Customers
Fosters a customer-focused environment.
Identifies and anticipates customer requirements, expectations, and needs.
Creates systems and processes that make it easy for customers to do business with CAI.
Lead Execution
Maintains accountability throughout the organization and encourages managed risk taking.
Delegates assignments to the lowest appropriate level and keeps people focused.
Monitors progress and redirects efforts when goals change or are not met.
Ensures people have resources, information, authority, empowerment, & support needed to achieve objectives.
Influence And Engage Others
Identifies the agendas, concerns, and motivations of others.
Negotiates persuasively to create win-win solutions for all parties.
Cultivates networks across the organization to garner support and create a foundation for future influence.
Inspires and coaches others to achieve beyond their own expectations and develop a winning mindset.
Build Talent
Provides feedback, coaching, and guidance where appropriate to enhance others’ skill development.
Shapes roles and assignments in ways that leverage and develop people’s capabilities.
Develops successors and talent pools to ensure availability of future talent.
Promotes the recruitment, advancement, and success of the best people from diverse backgrounds.
Achieve Results with People
Fosters a sense of energy, ownership, and personal commitment to the work.
Inspires others to stretch beyond what they thought they could do.
Encourages others to set challenging goals and high standards of performance.
Creates an environment in which performance excellence is rewarded.
Challenges self and others to learn and develop to improve capabilities.
Lead Courageously and Safely
Makes tough people and business decisions and challenges “the way it has always been done.”
Develops breakthrough ideas, safe working processes, initiatives, and business ventures.
DISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTERO
La selezione rispetta il principio delle pari opportunità (l. 903/77)
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Are You Ready?
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.
- We act with integrity
- We serve each other
- We serve society
- We work for our future
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:
- Major Area 1
Performs Batch Disposition preparation, Batch record review, Certification process oversight.
Strong cGMP and regulatory requirement understanding.
Experience In Trackwise.
Support all quality and compliance requirements for and leading to commercial manufacturing.
Uses knowledge to improve Quality Systems and/or Operational Quality with clients; solve complex problems and provide guidance and support for continuous improvement.
Understands and applies regulatory / compliance requirements to the role ensuring alignment and recommendation with current or upcoming regulatory and compliance changes.
Interprets client’s needs, assesses requirements, and identifies solutions to non-standard requests.
Ensure the highest Quality, Compliance and Safety standards
Works collaboratively to facilitate client and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality
Excellent Oral And Written English Are Required.
Suitable candidates must be available for travel throughout Italy and some European travel may be required.
La selezione rispetta il principio delle pari opportunità (l. 903/77)
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.
Apply Commercial Insights
Demonstrates understanding of financial and economic levers that impact business performance and deploys them to improve short- and long-term results.
Promotes best-in-class risk awareness and reviews risk management performance on a continuing basis.
Draws appropriate conclusions from financial reports and analyses to identify and evaluate major strategic priorities and investments.
Focus on Customers
Fosters a customer-focused environment.
Identifies and anticipates customer requirements, expectations, and needs.
Creates systems and processes that make it easy for customers to do business with CAI.
Lead Execution
Maintains accountability throughout the organization and encourages managed risk taking.
Delegates assignments to the lowest appropriate level and keeps people focused.
Monitors progress and redirects efforts when goals change or are not met.
Ensures people have resources, information, authority, empowerment, & support needed to achieve objectives.
Influence And Engage Others
Identifies the agendas, concerns, and motivations of others.
Negotiates persuasively to create win-win solutions for all parties.
Cultivates networks across the organization to garner support and create a foundation for future influence.
Inspires and coaches others to achieve beyond their own expectations and develop a winning mindset.
Build Talent
Provides feedback, coaching, and guidance where appropriate to enhance others’ skill development.
Shapes roles and assignments in ways that leverage and develop people’s capabilities.
Develops successors and talent pools to ensure availability of future talent.
Promotes the recruitment, advancement, and success of the best people from diverse backgrounds.
Achieve Results with People
Fosters a sense of energy, ownership, and personal commitment to the work.
Inspires others to stretch beyond what they thought they could do.
Encourages others to set challenging goals and high standards of performance.
Creates an environment in which performance excellence is rewarded.
Challenges self and others to learn and develop to improve capabilities.
Lead Courageously and Safely
- Develops and drives a safe and inclusive work culture.
Makes tough people and business decisions and challenges “the way it has always been done.”
Develops breakthrough ideas, safe working processes, initiatives, and business ventures.
DISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTERO
La selezione rispetta il principio delle pari opportunità (l. 903/77)
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Key Skills
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