QA Specialist in Sydney

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 environment.
• 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.
• Strong 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.