QA Specialist

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.

 

CAI is a 100% employee-owned company established in 1996, it has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.

Are You Ready?

 

 

Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.

As owners of 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.

 

With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.

 

CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market, including COVID19 Vaccines and therapies. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.

 

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.