Senior Quality Assurance Specialist

1 month ago


Perth, Western Australia Pharmiweb Full time

Job Summary:
We are seeking a highly skilled Senior Auditor, Quality Assurance to join our team at Pharmiweb. As a Senior Auditor, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

About the Role:
The Senior Auditor, Quality Assurance will be responsible for providing expert consultancy and compliance advice on technology-related topics, such as eClinical Systems and AI. You will perform internal process audits, technology vendor audits, computerized system and equipment audits. Additionally, you will perform Data Integrity Reviews of processes/systems and Validation Assessments of computerized systems. The ideal candidate will participate as a Technology-related Subject Matter Expert during inspections and sponsor audits and mentor and train junior staff.

Key Responsibilities:

  • Provide expert consultancy and compliance advice on technology-related topics, such as eClinical Systems and AI
  • Perform internal process audits, technology vendor audits, computerized system and equipment audits
  • Perform Data Integrity Reviews of processes/systems and Validation Assessments of computerized systems
  • Participate as a Technology-related Subject Matter Expert during inspections and sponsor audits
  • Mentor and train junior staff

Requirements:

  • Bachelor's degree in Life Sciences, Pharmacy, IT or related field; advanced degree preferred
  • Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, healthcare, or CRO industry
  • Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues
  • Proven auditing experience of computerized systems, processes, and vendors used in a clinical development and manufacturing setting
  • In-depth knowledge of data integrity, computerized system validation, delivery/service models, oversight frameworks, and emerging trends
  • Familiar with regulations governing clinical trials and drug development
  • Excellent communication and interpersonal skills

What ICON Offers:

  • Competitive salary
  • Annual leave entitlements
  • Health insurance offerings
  • Retail savings plan
  • Global Employee Assistance Programme
  • Life assurance
  • Flexible country-specific optional benefits

About ICON:
At Pharmiweb, diversity, inclusion, and belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. We're committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.



  • Perth, Western Australia Randstad Full time

    Job Title: Senior Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Senior Quality Assurance Specialist to join our Application Support and Maintenance team. The ideal candidate will have a minimum of 5 to 7 years of experience in software testing and a strong understanding of ICT systems and applications.Key Responsibilities:Provide...


  • Perth, Western Australia Monadelphous Full time

    At Monadelphous, we are seeking a skilled and experienced Senior Quality Assurance Specialist to join our Engineering Construction Division. This role will be based out of our Victoria Park office with ad hoc site visits when required.We offer a competitive salary of $120,000 - $180,000 per annum, depending on experience. Our company is built over 50 years,...


  • Perth, Western Australia Pyramid Global Technologies Full time

    About Pyramid Global TechnologiesWe are offering a competitive salary of $85,000 - $110,000 per annum.Job Description:As a Senior Quality Assurance Specialist at Pyramid Global Technologies, you will be responsible for performing functional and technical testing to ensure the highest quality of our products.The ideal candidate will have experience working in...


  • Perth, Western Australia Monadelphous Full time

    About the RoleWe are seeking an experienced Senior Quality Assurance Specialist to join our team in the Energy sector. As a key member of our operations, you will be responsible for implementing and maintaining quality management policies and procedures across our Tier 1 client contracts.


  • Perth, Western Australia Monadelphous Full time

    Role OverviewWe are seeking a highly skilled Senior Quality Assurance Specialist to join our Energy team. This role will see you working across our Tier 1 client contracts, providing implementation and ongoing improvement strategies.Key Responsibilities:Support the implementation of our Quality Management policy, system, and strategies.Communicate and...


  • Perth, Western Australia Pyramid Global Technologies Full time

    About Pyramid Global TechnologiesWe are committed to delivering high-quality software solutions, and we're seeking a skilled Quality Assurance Specialist to join our team.As a Quality Assurance Specialist at Pyramid Global Technologies, you will be responsible for ensuring the quality of our software products by performing functional and technical testing,...


  • Perth, Western Australia The University of Western Australia Full time

    At The University of Western Australia, we are seeking a Quality Assurance Specialist to play a pivotal role in establishing and managing our Quality Management System (QMS) for RNA Innovation Foundry.We require a professional with relevant tertiary qualifications in Pharmacy, Chemistry, Microbiology, or Biochemistry, or demonstrated equivalent competency....


  • Perth, Western Australia The University of Western Australia Full time

    At The University of Western Australia, we are seeking an experienced Quality Assurance Specialist to play a key role in establishing and managing our Quality Management System (QMS) for RNA Innovation Foundry.We require someone with demonstrated experience designing, implementing and monitoring a QMS within a healthcare organisation, focusing on Quality...


  • Perth, Western Australia The University of Western Australia Full time

    Company Overview:The University of Western Australia is a leading research institution seeking an experienced Quality Assurance Specialist to join its RNA Innovation Foundry team.About the Role:This full-time position involves establishing and managing the Quality Management System (QMS) to ensure compliance with quality system, good manufacturing/laboratory...


  • Perth, Western Australia Monadelphous Full time

    We are seeking a skilled Electrical Quality Assurance Specialist to join our team in the Resource Sector. In this role, you will have the opportunity to work on large-scale electrical projects, ensuring the highest quality standards are met.Our team at Monadelphous provides multidisciplinary project management and construction services through specialized...


  • Perth, Western Australia Monadelphous Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for providing implementation and ongoing improvement strategies across our Tier 1 client contracts.This is an office-based position with occasional site travel requirements.


  • Perth, Western Australia Pyramid Global Technologies Full time

    About Pyramid Global TechnologiesWe are currently seeking a highly skilled Senior Quality Assurance Lead to join our team in Perth.Job Description:The Senior Quality Assurance Lead will be responsible for creating and executing test scripts, recording testing outcomes, and reporting on testing progress in JIRA. This includes daily progress stand-ups,...


  • Perth, Western Australia Monadelphous Full time

    About the RoleWe are seeking a Quality Assurance Specialist to join our Energy team, providing implementation and ongoing improvement strategies across Tier 1 client contracts.Key ResponsibilitiesSupporting the development and execution of the Monadelphous Quality Management policy, system, and strategiesCommunicating and contributing towards a positive...


  • Perth, Western Australia Clough Group Full time

    About the OpportunityWe are seeking an experienced Quality Assurance Specialist to join our team at Clough Group in Karratha.As a key member of our project team, you will be responsible for providing administrative support to the Project Quality Manager and ensuring compliance with regulations.Key ResponsibilitiesCoordinate quality documentation and manage...


  • Perth, Western Australia Ventia Full time

    Quality Assurance Auditor Opportunity with VentiaVentia is seeking a highly skilled Quality Assurance Auditor to join their team in Australia.This is an exciting opportunity to work for one of Australia's largest dedicated infrastructure service providers, utilising expertise in transmission, distribution, and the maintenance of large complex assets.The...


  • Perth, Western Australia Planit Full time

    Job OverviewWe are seeking a highly skilled Advanced Quality Assurance Specialist to join our team at Planit. As a key member of our quality engineering department, you will be responsible for ensuring the highest standards of quality in our software development lifecycle.


  • Perth, Western Australia CPB Contractors Full time

    Role OverviewCPB Contractors, a leading infrastructure construction company, is seeking a highly skilled Quality Assurance Specialist to join our team for the Western Ridge Crusher Project in Newman.The successful candidate will be responsible for ensuring the highest quality standards are met throughout the project, working closely with our clients and...


  • Perth, Western Australia Planit Full time

    About the RoleWe are seeking an experienced Senior Quality Assurance Manager to join our team in Perth. As a key member of our quality engineering team, you will be responsible for leading and mentoring our quality assurance professionals.Job Description:Develop and implement comprehensive quality assurance strategies and plansLead and mentor a team of...


  • Perth, Western Australia Pyramid Global Technologies Full time

    About Pyramid Global TechnologiesPyramid Global Technologies offers a competitive salary range of $85,000 - $110,000 per year.About the JobThis role involves performing functional and technical testing to ensure high-quality software products. Key responsibilities include:Performing integration testing to identify issues early in the development...


  • Perth, Western Australia Sense Recruitment Full time

    About the RoleWe're seeking a motivated and detail-oriented Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the accuracy and accessibility of our documentation.Key ResponsibilitiesCollaborate with colleagues to maintain high-quality documentationSupport audits and ensure critical...