Qa Associate

About Us

IDT Limited is an ASX listed company with a 50 year heritage in Australian biotech partnering with a broad range of clients around the globe through the Americas, Europe and Asia Pacific focused on the development and scale up into clinical phase and commercial manufacture of high containment, specialised pharmaceuticals that treat a broad range of disease and health needs. We are building our team as IDT embarks on a growth and transformation plan. 

The Role
Due to an exciting period of growth, we have a great opportunity for an experienced QA Associateto join a high performing and supportive team. 

The core purpose of this role is to provide client partnership, advice and execution of the Quality Excellence framework for IDT. This will be achieved through partnering with clients 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 will achieve this through supporting Quality activity in process in real time with the client in situ to create better work flows and better customer delivery on critical activities in particular as they relate to Batch Release. 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. 

Other responsibilities include:

• Proactively drive down deviations, CAPA’s and improve batch flow and deliver on customer commitments and key Quality metrics and indicators. 
• Ensures all Operational Quality activities relating to Batch Release of IDT product to customers is completed in full and on time as required. 
• Has experience and capability to advise and support IDT activities as they pertain to their client groups - Specialty Orals, API and Advanced Therapies.
• Helps coach, advise and partner with the business to adopt Quality Excellence framework built on lead measures to achieve a Right First Time and Zero Defect quality culture in situ through the day to day Quality activities. 
• Actively participate and contribute to site meetings as required to help drive organisation performance. 
• Provides a key support in the effective adoption and transition from a paper based system to an eQMS and the effective integration of that platform into the business and day to day Quality practices of the organisation.
• Provides in process audit and review of trends and data and in partnership with clients and Quality Manager(s) to support the internal review and audit of practices. 
• Provides critical incident support to help investigate and problem solving and root cause analysis tools to ensure effective analysis and resolution of Operational Quality issues.  

 About You

The successful candidate will come with:

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.

• A minimum of 5 years in a similar QA role within the pharmaceutical industry preferably with exposure to sterile
• Solid Pharmaceutical Quality regulatory environment understanding
• Systems thinking and LEAN principles and Operations Excellence 
• Sterile experience, knowledge and capability to design Quality system process 
• Demonstrated capability applying key cGMP, Quality, Validation, Scientific and Testing 
• Demonstrated ability to influence, negotiate and work with people throughout all levels of the organisation 
• 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. 
• A collaborative attitude and ability to communicate with a wide range of internal peer groups and departments across IDT.
• Operations experience would also be an advantage

Why Work for Us:

At IDT we value Ownership & Accountability, Trust & Integrity, Adaptability, Teamwork & Collaboration, Innovation & Problem Solving. 

We are an equal opportunity employer.  Diversity, inclusion, flexibility, ongoing development, and a supportive workplace culture are a big part of the way we work.

If you join IDT you are joining a small collaborative team that values excellence.

Applications

This role is subject to a national police record check and employment medical.

Applicants must be an Australian Citizen, Permanent Resident or hold a valid work permit or visa. Work eligibility will be checked as part of the recruitment process.