QA Specialist

About the Role

CAI is hiring QA Specialists in Australia with hands-on experience across commissioning, qualification, and validation. This role is focused on regulated environments, particularly within pharmaceutical, medical device, or biotechnology settings.

About CAI

CAI is a fully employee-owned organisation founded in 1996. It has expanded steadily to almost 700 people across the world. The company delivers commissioning, qualification, validation, startup, project management, and consulting services that support operational readiness for FDA-regulated and other mission-critical industries.

Working Style and Culture

CAI’s approach is built around putting the client first, continuing until the outcome is right, and doing what it takes to achieve it. As employee-owners, the team follows core principles that emphasise integrity, service to one another, service to society, and responsibility for the future. The culture is collaborative, team-focused, respectful, and strongly action-oriented. Employees are also exposed to advanced technologies in the medicine space and may work alongside subject matter experts on therapies and vaccines, including COVID-19-related work. The company also supports professional growth through hands-on certifications and training.

Role Summary

The position supports validation work across equipment, cleaning, analytical processes, and software, while helping maintain compliance, documentation quality, and schedule adherence. The role also involves working with cross-functional teams, contributing to risk management, and supporting inspection readiness and regulatory response activities.

Key Responsibilities

• Partner with the Validation Manager to help deliver validation objectives.
• Support validation projects from launch through completion, keeping them on schedule and within budget.
• Coordinate with cross-functional teams and maintain clear communication throughout the project lifecycle.
• Assist with testing and validation of equipment, cleaning processes, analytical methods, and software.
• Help create, implement, review, and approve validation plans, protocols, procedures, and reports.
• Ensure validation testing, documentation, and related activities are completed accurately and efficiently.
• Apply risk management practices to protect product quality and compliance.
• Identify validation-related risks and contribute to mitigation plans.
• Carry out risk assessments to spot possible process or product issues.
• Maintain validation procedures aligned with company policies and regulatory requirements.
• Work to validation schedules and support timely execution of activities.
• Track, report, and analyse validation activity trends and results.
• Keep management informed about departmental performance, emerging trends, and changes that may affect the facility.
• Work with internal stakeholders to resolve validation issues and keep validation integrated into the broader project timeline.
• Support preparation and review of Product Quality Reviews / Annual Product Reviews where needed.
• Communicate with internal and external stakeholders on projects, products, and validation matters.
• Carry out additional job-related duties as assigned.
• Support regulatory inspection and audit preparation linked to validation activities.
• Help draft clear and comprehensive responses to audit observations.
• Support the company’s data integrity and inspection readiness programs.
• Apply knowledge of TGA and other relevant regulatory guidance to support cGMP compliance.
• Promote an open, supportive, values-led workplace.
• Use broad cGMP knowledge to mentor and guide Quality, Operations, Analytical, Logistics, and Engineering teams.
• Contribute to continuous improvement initiatives and business goals.
• Take part in internal meetings, events, and activities as required.

Requirements

• A bachelor’s degree in engineering, life sciences, quality assurance, or a related discipline is required.
• Advanced qualifications in validation or quality systems are considered an advantage.
• At least 2 years of experience in validation, quality assurance, or a related discipline is required.
• Direct experience in validation within a relevant industry is needed.
• Strong knowledge of FDA, EMA, ISO, PDA, and ISPE requirements relevant to validation work is essential.
• Experience with validation management software, electronic documentation systems, and risk tools is preferred and, in some cases, required.
• Solid project management capability is important for supporting multiple validation activities.
• Strong analytical ability is needed to assess validation data and identify trends.
• Understanding of software validation, equipment qualification, and process validation methods is required.
• Ability to adapt to changing regulations, technologies, and industry standards is important.
• Good knowledge of cGMP and GMP expectations at both national and international levels is required.
• Excellent attention to detail and sound decision-making skills are important.
• Strong understanding of quality management principles and a commitment to quality and compliance are expected.

Additional Information

The hiring process may use artificial intelligence tools to assist with reviewing applications, analysing resumes, assessing responses, and flagging potential inconsistencies or verification signals. These tools support the recruitment team but do not replace human evaluation. Final hiring decisions are made by people. If more information is needed about how data is processed, the candidate can contact the company directly.