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QUALITY ASSURANCE MANAGER

vor 4 Wochen


austria at Vollzeit

Quality Assurance & Control (Science & Technology)

Are you an experienced Quality Assurance Professional with a passion for quality and a commitment to maintaining the highest standards? Our rapidly growing contract testing laboratory is seeking a full time Quality Assurance Manager to join our team. In this role you'll lead our quality management initiatives and ensure the highest standards across our operations.

Responsibilities:

1. Participating in the design, establishment and maintenance of programs and processes that ensure quality systems and compliance with current TGA, APVMA and GMP Guidelines

2. Maintenance of accurate and comprehensive quality records, documentation, and reporting systems in compliance with regulatory requirements

3. Review the summary of test results generated and issue Certificates of Analysis to clients

4. Development, timely review, and control of documentation for all quality activities and laboratory operations

5. Oversee the investigation of deviations, complaints and other non-conformances and implement corrective and preventive actions (CAPA) as necessary

6. Coordinate and facilitate internal and external audits and inspections by regulatory authorities and clients to assess compliance with quality standards and identify opportunities for improvement

7. Provide quality assurance training and guidance to laboratory personnel on quality systems, procedures, and regulatory compliance

8. Serve as the primary liaison with regulatory agencies, clients, and other stakeholders on quality-related matters.

9. Participate in the selection, qualification, and monitoring of critical suppliers and vendors.

10. Prepare GMP Agreements between the business and clients

11. Oversee the change control program

12. Oversee the risk management program

13. Oversee the validation and qualification program

14. Monitor and report trends in all aspects of the QMS including deviations, CAPA, complaints

15. Participate in and provide quality management data for the Management Review

16. Review of temperature and humidity data monitoring for stability rooms and other controlled environments

17. The Quality Assurance Manager will be the Authorised Person for Release for Supply

The successful applicant will have the following:

  • Bachelor of Science or related discipline
  • Understanding of regulatory guidelines and standards in pharmaceutical, veterinary, or complementary medicine industries
  • A minimum 5 years in a TGA / GMP laboratory
  • High proficiency in writing technical documents and procedures
  • Strong organizational skills and attention to detail, with the ability to multitask and prioritize effectively
  • Excellent problem-solving, critical thinking, and decision-making abilities.
  • Team Player
  • Experience in an analytical chemistry and/or microbiology laboratory would be highly regarded
  • Experience with batch release or Release for Supply would be highly regarded
  • Experience in a leadership or supervisory role is desirable
  • Customer Service experience is also desirable

We are offering acompetitive compensation package to the successful candidate. If you think the above position sounds like you, please submit your resume and a cover letter highlighting your relevant experience and qualifications via the link.

Your own transport is essential.

Your application will include the following questions:

  • Which of the following statements best describes your right to work in Australia? How many years' experience do you have as a Quality Assurance Manager? Have you completed a qualification in science? Do you have technical writing experience? Have you worked in a role where you were responsible for authoring and reviewing technical documentation? Have you worked in a role which requires a sound understanding of Good Manufacturing Practices (GMP)?

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