Senior Quality Assurance Specialist

3 weeks ago


Sydney, New South Wales, Australia Sobi Full time

Job Title: Quality Assurance Specialist



About the Role:




  1. Develop and maintain quality standards to support Sobi's practices in Australia.
  2. Implement systems and processes to ensure Sobi products consistently meet or exceed established quality standards.
  3. Lead activities related to Good Manufacturing Practices (GMP), Quality Management Systems (QMS), and adherence to regulatory requirements.


Responsibilities:




  1. Oversee the Sobi QMS in Australia, including training and updates.
  2. Collaborate with Supply Chain to ensure quality standards are met.
  3. Review records and change requests.
  4. Approve GxP documents.
  5. Prepare batch release documentation.
  6. Support Corrective and Preventative Actions (CAPAs) and continuous improvement.


Compliance:




  1. Communicate compliance requirements and train staff.
  2. Manage the transfer of value (ToV) data and reporting.
  3. Coordinate Email and Consent capture according to privacy laws.
  4. Conduct regular compliance monitoring.


Qualifications:




  • Relevant qualification in Quality Assurance and Compliance.
  • 5+ years' experience in quality systems management within a pharmaceutical industry environment.
  • Familiarity with Regulatory Standards (TGA, FDA, and ISO-9001).
  • Excellent analytical, problem-solving, organisational, and communication skills.


About Sobi:



Sobi is a pharmaceutical company committed to improving the lives of patients.



How to Apply:



Please submit your application according to Sobi's guidelines.



Disclaimer:



All information will be kept confidential according to EEO guidelines.



  • Sydney, New South Wales, Australia Wärtsilä Full time

    Quality Assurance SpecialistWärtsilä is a leading technology company that aims to enable sustainable societies through innovation in technology and services. As a Quality Assurance Specialist, you will play a vital role in ensuring the quality of our products and services.ResponsibilitiesDevelop and maintain quality assurance plans and proceduresConduct...


  • Sydney, New South Wales, Australia HiTech Group Full time

    Job OverviewWe are seeking a skilled Senior Quality Assurance Specialist to join our team at HiTech Group.This is a 12-month contract with the possibility of extension for up to 24 months.


  • Sydney, New South Wales, Australia EBR Full time

    We are looking for a highly skilled and motivated Senior Quality Assurance Specialist to join our team at EBR. This is an exciting opportunity for individuals who are passionate about quality assurance and eager to learn and grow with our company.About the Role:Job Summary:The successful candidate will be responsible for assisting with all QA/QC daily...


  • Sydney, New South Wales, Australia REA Group Full time

    About the RoleAs a Senior Quality Assurance Specialist, you will play a pivotal role in ensuring the high quality of our property data pipelines and APIs. You will work closely with cross-functional squads to implement quality strategies, monitor data quality, and identify areas for improvement. Your expertise in data testing, data quality frameworks, and...


  • Sydney, New South Wales, Australia Bio-Rad Full time

    We are currently seeking a Senior Quality Assurance Specialist to join our team in Sydney, supporting our Pacific business.Job DescriptionAs a Senior Quality Assurance Specialist, you will be responsible for maintaining and optimizing Bio-Rad's quality management system. You will work closely with the commercial organization to develop, review, and update...


  • Sydney, New South Wales, Australia Charterhouse Full time

    Job OverviewWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Charterhouse.Compensation and BenefitsThe successful candidate can expect a competitive salary of up to $750 per day, plus superannuation benefits.Job DescriptionAs a Senior Quality Assurance Specialist, you will be responsible for testing the functionalities...


  • Sydney, New South Wales, Australia Wärtsilä Full time

    As a Senior Quality Assurance Specialist at Wärtsilä, you will play a crucial role in ensuring the quality of our innovative technologies and services. Our company is a forerunner in the Marine and Energy markets, dedicated to enabling sustainable societies through innovation.We are passionate about turning our purpose into reality every day. Our ultimate...


  • Sydney, New South Wales, Australia Hudson Australia Full time

    We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Hudson Australia.This is a great opportunity for someone who enjoys working in the grant administration space and has excellent quality assurance skills.The successful candidate will have experience in providing high-quality assurance of offer and execution phases of the...


  • Sydney, New South Wales, Australia Aston Advantage Full time

    Aston Advantage is seeking a skilled Senior Quality Assurance Specialist to join our team in Liverpool.Estimated Salary: $90,000 - $115,000 per annumAbout the Role:We are looking for an experienced Manufacturing expert with strong analytical skills and proven quality compliance experience to ensure product excellence by auditing materials, interpreting...


  • Sydney, New South Wales, Australia Aston Advantage Full time

    Aston Advantage is a global leader in the mining and construction industry, specializing in water, sound, and air solutions. We are seeking an experienced Senior Quality Assurance Specialist to join our team.**Opportunity Summary:**We are looking for a highly skilled professional to ensure product excellence by auditing materials, interpreting technical...


  • Sydney, New South Wales, Australia Aston Advantage Full time

    Aston Advantage is a global leader committed to employee welfare, promoting from within, and investing in growth opportunities worldwide.We are currently seeking a skilled Senior Quality Assurance Specialist to join our team in Liverpool.The successful candidate will have experience in manufacturing and strong analytical skills with proven quality compliance...


  • Sydney, New South Wales, Australia Talent Focus Full time

    Are you ready to thrive in a dynamic environment that advances scientific research and supports industry?We are seeking a talented individual to fill the role of Senior Quality Assurance Specialist, where you will be responsible for ensuring the highest standards of quality control.The Benefits:Enjoy a competitive salary package with above standard...


  • Sydney, New South Wales, Australia Blackbook Recruitment Full time

    Market Leading Opportunity">This is an exciting chance to join a global food business as a Senior Quality Assurance Specialist, based in West Sydney. Reporting directly to the FSQ Manager, you will be part of the quality team, driving initiatives and providing technical expertise on daily issues.">About the Role">Drive FSQ initiatives, provide technical...


  • Sydney, New South Wales, Australia Finite IT Recruitment Full time

    Finite IT Recruitment is seeking an experienced Senior Quality Assurance Specialist to join their team on a short-term assignment with an immediate start. The ideal candidate will have a strong background in quality assurance, particularly in the New Payments Platform (NPP), and excellent testing skills. As a key member of the project team, you will be...


  • Sydney, New South Wales, Australia Talent Focus Full time

    Are you looking for a challenging role in a dynamic environment?Talent Focus is committed to delivering innovative solutions that advance scientific research and support industry.As a Senior Quality Assurance Specialist, you will be responsible for maintaining project files and QC records ensuring work meets strict control guidelines.Key...


  • Sydney, New South Wales, Australia EBR Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Senior Quality Assurance Specialist to join our team in the pharmaceutical industry.As a Senior Quality Assurance Specialist, you will be responsible for ensuring compliance with regulatory requirements and internal standards, maintaining quality systems, and implementing process...


  • Sydney, New South Wales, Australia Talenza Full time

    Quality Assurance SpecialistOur client, a leading Australian brand, is seeking a Quality Assurance Specialist to join their team on a large-scale transformation project. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of the company's products and services.Key Responsibilities:Collaborate with BAs and Engineers to develop...


  • Sydney, New South Wales, Australia Canva Full time

    About the RoleCanva is seeking a skilled Quality Assurance Specialist to join their team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of Canva's products and services.Key ResponsibilitiesDevelop and implement quality assurance processes and proceduresCollaborate with cross-functional teams to identify and prioritize...


  • Sydney, New South Wales, Australia EML (Employers Mutual Limited) Full time

    The OpportunityEML is seeking a Quality Assurance Specialist to drive internal and external audit outcomes. This role will work closely with the Senior Leadership Team, Case Managers, and Insurers to coordinate quality assurance and regulator audit responses. The successful candidate will be responsible for implementing continuous improvement activities...


  • Sydney, New South Wales, Australia Wärtsilä Full time

    Quality Assurance Specialist Job DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at Wärtsilä. This is a unique opportunity to work with a leading technology company that is dedicated to enabling sustainable societies through innovation in technology and services. Our team is passionate about delivering high-quality...