Qa Associate
vor 1 Woche
Company Description
Founded in 1975, IDT Australia is a publicly listed pharmaceutical manufacturing company based in Boronia, Victoria. We provide comprehensive services, from early-stage API development to finished drug formulation and scaled commercial manufacturing for global distribution. Our facilities are cGMP compliant and regularly audited by the US FDA and Australian TGA. At IDT, we value accountability, leadership, curiosity, quality, innovation, and driving results.
Role Description
We are seeking a full time permanent QA Associate - Projects, to work onsite at our Boronia based facility.
The core purpose of the QA Associate Projects is to provide client partnership, advice and execution of the Quality Excellence framework for IDT. This will be achieved through partnering with clients internally and externally as required to be an In Process and On-the-Floor Quality champion for the adoption of Quality Excellence activities as they pertain to adopting practices to achieve Right First Time and Zero-Defect culture and organisation performance.
The QA Associate Projects is a key partner in providing Quality oversight of projects utilizing technical expertise to ensure compliance and phase appropriate levels of quality are applied. The role is also responsible for helping transition from a reactive lag measure Quality System to a proactive lead measure focused preventative built in Quality focus to drive down Deviations and CAPA's and overdue Quality Metrics. The Quality Associate partners with internal clients to help them build on their Quality Culture and improvements to build a Right First Time and Zero-Defect culture.
The QA Associate Projects will achieve this through supporting Quality activity in process in real time with the client in situ to create better workflows and better customer delivery on critical activities. The Quality Associate is a champion in helping ensure the right Quality focus and measures are applied to ensure IDT delivers on its Customer, Quality and Cost commitments.
Qualifications and Skills
Minimum requirement for this position is a Science or Chemical Engineering degree or relevant discipline.
LEAN or Six Sigma certified will also be very well regarded.
• 5 years plus experience in the Pharmaceutical or Biotech industry with a demonstrated Operations, Process Development / Validation and Quality background through cGMP stages for development, clinical and commercial grade manufacture. Preferably with Sterile and Aseptic practice environments.
• Solid analytical and technical skills to effectively analyse data and trends and analyse inputs for effective advice to project teams, root cause analysis, problem solving and decision making.
• Solid Pharmaceutical Quality regulatory environment understanding and experience to understand and apply regulatory standards, codes and industry standards to Quality system and framework applications.
• Systems thinking and LEAN principles and Operations Excellence experience to support Right First Time, Zero Defects, In Process Quality, eQMS and Quality Transformation to build a high-performance culture and framework.
• Sterile experience, knowledge and capability to design Quality system process and frameworks to deliver on industry standards capability through different types of development and manufacture process for aseptic filling, freeze drying, formulation and packaging are highly desirable.
• Demonstrated capability applying key cGMP, Quality, Validation, Scientific and Testing processes and systems to ensure effective process and manufacture.
• Demonstrated ability to influence, negotiate and work with people throughout all levels of the organisation and with key partners, stakeholders and clients to deliver on IDT requirements, especially in client groups to adopt Quality ways of working.
• Strong interpersonal skills to consult, advise and partner with client groups – interpersonal skills to provide a key Quality advisory role on the floor in process and in real time to problem solve and review Quality practices to achieve outcomes in a timely and effective manner.
• Lateral thinking to help ensure a Fit for Purpose Quality application to ensure the Quality Excellence framework applies effectively and appropriately to research and development projects and the right application to commercial manufacture batches and applications.
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