QA Specialist

CAI, Melbourne

What you need

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

All jobs

QA Specialist

CAI, Melbourne

What you need

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

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.

QA Specialist

What you need

QA Specialist

What you need

Our approach is simple because our Purpose informs everything we do

At CAI, we are committed to living our Foundational Principles, both professionally and personally

Validation

Regulatory Compliance

Training and Development

Other Duties

About CAI

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