QA Validation Specialist — Life Sciences & Compliance

Cagents; City of Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

CAI in Melbourne, Australia is seeking a Validation professional to support validation goals and project delivery within life sciences and quality systems.

You will collaborate with cross-functional teams, develop validation plans, assess risks, and ensure compliance with regulatory guidelines and GMP practices. This role offers a structured path to impact product quality and compliance.

Qualifications

• Demonstrated experience in Validation in a relevant or related industry.
• Bachelor’s degree in a relevant field such as engineering, life sciences, or quality assurance.
• Knowledge of FDA, EMA and ISO regulations including PDA and ISPE pertinent to validation activities.
• Proficiency in validation management software and electronic documentation systems.

Responsibilities

• Work closely with the Validation manager to ensure completion of validation goals and objectives.
• Support validation projects from initiation to completion, ensuring on-time and within-budget delivery.
• Support testing and validation of equipment, cleaning processes, analytical processes, and software.
• Develop and implement validation plans, protocols, and procedures.
• Evaluate and approve validation plans, protocols, and reports for completeness and accuracy.
• Maintain validation activities within the project lifecycle and track performance trends.
• Communicate with internal and external stakeholders regarding validation projects.

Skills

Analytical skills

Risk management

Project management

Attention to detail

Quality mindset

Education

Bachelor's degree in engineering, life sciences, or quality assurance

Advanced degrees or certifications in validation or quality systems

Tools

Validation management software

Electronic documentation systems

Risk management tools

Job description

CAI in Melbourne, Australia is seeking a Validation professional to support validation goals and project delivery within life sciences and quality systems.

You will collaborate with cross-functional teams, develop validation plans, assess risks, and ensure compliance with regulatory guidelines and GMP practices. This role offers a structured path to impact product quality and compliance.