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Data Integrity Specialist
2 weeks ago
CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.
About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Are You Ready?
Our approach is simple; we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of 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
With employee ownership, one person's success is everyone's success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market, including COVID19 Vaccines and therapies. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
About The Role
Are you passionate about quality, compliance, and ensuring the accuracy of data in a regulated environment? We are seeking a Data Integrity Specialist to join our growing Quality team in Sydney.
This permanent role is central to safeguarding the accuracy, consistency, reliability, and security of data across its lifecycle. You'll help design and implement robust data integrity standards, support compliance initiatives, and drive continuous improvements to ensure operational excellence.
Work Location: Sydney, Australia
Employment Type: Full Time Employee
Requirements Include
- Bachelor's degree (or equivalent) in a scientific or technical discipline, or relevant experience in GxP Quality Assurance.
- Strong understanding of GMP environments and regulatory requirements.
- Demonstrated knowledge of Data Integrity principles.
- Excellent attention to detail, analytical skills, and problem-solving ability.
- Strong communication and interpersonal skills, with the ability to work across functions.
- Proactive, adaptable, and resilient, with a focus on delivering results.
- A proven team player who takes initiative and thrives in a dynamic environment.
- Australia/New Zealand PR or Citizen
Position Requirements
- Lead the organisation's Data Integrity program, including the development of policies, procedures, and risk assessments.
- Review and approve documentation such as SOPs, change controls, and audit trails related to data integrity.
- Monitor systems and processes for compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11) and industry best practices.
- Support internal and external audits, inspection readiness, and regulatory compliance initiatives.
- Investigate and resolve data integrity issues, ensuring effective corrective and preventive actions.
- Deliver training on data integrity principles to staff across multiple departments.
- Collaborate with cross-functional teams to support projects, products, and validation activities.
- Identify and lead process improvement opportunities to enhance quality systems and compliance
Why Join?
We are a rapidly growing organisation at the forefront of health, science, and technology. With a strong focus on innovation and excellence, we are dedicated to improving lives by delivering high-quality products and services in a highly regulated environment. Our people are at the heart of what we do, and we foster a values-driven culture that embraces diversity, collaboration, and continuous improvement.
You'll be part of an organisation that takes pride in delivering high-quality outcomes. We foster an inclusive, collaborative, and supportive culture where continuous improvement, innovation, and professional development are encouraged.
