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.

Responsibilities

Validation

- Work closely with the Validation manager to ensure completion of validation goals and objectives.
- Support validation projects from initiation to completion, ensuring they are delivered on time and within budget.
- 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.
- Ensure that all aspects of validation, testing, and documentation are completed in a timely and efficient manner.
- Utilise effective risk management to maintain 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 of validation activities and results.
- Ensure management is aware of validation department performance, trends in products/processes, and changes that could impact the facility.




- Track and 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.
- Support compilation and review of Product Quality Reviews/A Annual Product Reviews, as appropriate.
- Communicate with internal and external stakeholders regarding projects, products, and other validation related topics.
- Perform 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 holistic manner.
- Support the 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 workplace.
- Utilise a broad understanding of cGMP to provide Validation support, mentoring and coaching for Quality, Operations, Analytical, Logistics and Engineering departments.

Other Duties





- Identify continuous improvement opportunities and implement solutions to improve programs and meet business goals.
- Participate in internal meetings/events/activities as required.

Qualifications

- 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.
- Minimum of 2 years of experience in validation, quality assurance, or a related field.
- Solid understanding of FDA, EMA, and ISO regulations including PDA and ISPE pertinent to validation activities.
- Proficiency in validation management software such as or similar tools is required. Experience with electronic documentation systems and risk management tools is also beneficial.
- Good project management skills for supporting validation projects effectively.
- Excellent analytical skills to assess validation data and identify trends.
- Familiarity with relevant technology and systems used in validation processes, including software validation, equipment qualification, and process validation techniques.
- Ability to adapt to changing regulations, technologies, and industry standards.
- Good knowledge of CGMP and GMP regulatory requirements nationally and internationally.
- 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.

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📌 QA Specialist (City of Sydney)
🏢 Cai
📍 City of Sydney