Quality Assurance Specialist

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:
• 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.

 

Validation:

•Work closely with the Validation manger to ensure completion of validation goals and objectives.

• Support validation projects from initiation to completion, ensuring they are delivered on time and within budget. This requires coordinating with cross-functional teams and maintaining clear communication throughout the project lifecycle.

• Support the testing and validation of equipment, cleaning processes, analytical processes, and software.

• Support the development and implementation of validation plans, protocols, and procedures.

• Evaluate and approve validation plans, protocols, and reports to ensure completeness and accuracy. 

• Within validation projects ensure that all aspects of validation, testing, and documentation are completed in a timely and efficient manner.

• Utilisation of effective risk management is crucial for maintaining product quality and compliance.

• Identify potential risks associated with validation processes and support the development of mitigation strategies.

• Conduct risk assessments to identify potential issues in products and processes.

• Establish and maintain validation procedures and processes that meet company policies and applicable regulations.

• Work to schedules for validation activities to ensure timely execution and completion.

• Participate in the tracking, reporting and trending validation activities and results.

• Ensure management is aware of validation department performance, trends in products/processes, and changes that could impact the facility.

• Track & trend processes to monitor validation department performance.

• Work closely with cross-functional teams to resolve validation issues and to ensure all products and processes are validated accurately and efficiently. Ensure validation activities are integrated into the overall project lifecycle.

• Support compilation and review of Product Quality Reviews/ Annual Product Reviews, as appropriate.

• Communicate with internal and external stakeholders regarding projects, products, and other validation related topics.

• Performs other job-related duties as assigned. 

Regulatory Compliance:

•Responsible for compliance with relevant regulations, legislation, and standards.

• Support preparation efforts for regulatory inspections and audits related to validation activities.

• Support the Generation of audit responses to observations in a clear and wholistic manner

• Support company Data integrity program.

• Support the inspection readiness program.

• Knowledge of relevant TGA and regulatory guidelines to ensure cGMP compliance. 

Training and Development:

• Proactively foster an open, supportive, values-based culture, and work environment.

• Utilise a broad understanding of cGMP to provide Validation support, mentoring and coaching for Quality, Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and internal procedures, as appropriate. 

Other Duties:

• Identify continuous improvement opportunities and implement solutions to improve programs and meet business goals.

• Participating in Internal meetings/events/activities as required. 

 

Requirement: 

•  A bachelor’s degree in a relevant field such as engineering, life sciences, or quality assurance is essential. Advanced degrees or certifications in validation or quality systems can be advantageous.

Demonstrated experience in Validation in a relevant or related industry.

• A minimum of 2 years of experience in validation, quality assurance, or a related field is required.

• Strong understanding of FDA, EMA, and ISO regulations including PDA and ISPE pertinent to validation activities is crucial.

• Proficiency in validation management software such or similar tools is required. Experience with electronic documentation systems and risk management tools is also beneficial.

• Good project management skills are necessary for supporting validation projects effectively.

• Excellent analytical skills are required to assess validation data and identify trends.

• Familiarity with relevant technology and systems used in validation processes is necessary. This includes understanding software validation, equipment qualification, and process validation techniques

• The ability to adapt to changing regulations, technologies, and industry standards is crucial for success in this role.

• Good knowledge CGMP and GMP regulatory requirements nationally and internationally as required.

• Excellent attention to detail and decision making skills.

• Demonstrated knowledge and understanding of quality management principles, and a commitment to fostering a culture of quality and compliance.