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SalaryAn exciting job opportunity is now open as a Quality Assurance Associate in our Animal Health business. This position is a part time, 12-month fixed-term contract based in our head office in Sydney and will report directly to the Head of Commercial Quality.
You will perform the tasks required by the BI Pharmaceutical Quality System (PQS) as they apply to Australia & New Zealand to ensure compliance with current regulatory requirements. This position sits within the Quality Systems & Compliance (QS&C) sub-team. QS&C is that part of Commerical Quality whose primary focus is non-transactional tasks i.e., maintenance of the Quality System, Supplier Qualification, Self-Inspections etc.
Tasks & Responsibilities
- Support the management of the local third-party Supplier Lifecycle Management Program in accordance with applicable local regulations and corporate requirements, including supplier selection, supplier evaluation, supplier qualification, maintenance of Quality Assurance Agreements, auditing support and ongoing monitoring of processes, supplier with issue cases and supplier termination.
- Maintenance of quality system processes & related documentation i.e., SOPs, Quality Agreements, Supplier Management etc.
- Raise and review deviations, associated investigations, CAPAs & Change Control records as per approved procedures and as may be necessary.
- Monitor quality related processes in accordance with defined KPIs and prepare associated reports for the Quality Management Review process, including trending of data and determination of actions to reverse adverse trends or improve system compliance.
- Participate in the development and implementation of local quality related processes and procedures, ensuring compliance with applicable local regulations and Corporate requirements.
- Support the ongoing development of the local training programme for QA, and other relevant business functions, via maintenance of the programme and development & delivery of material.
- Maintain appropriate quality records as required by applicable procedures.
- Provide support for the release-for-distribution function as may be necessary from time-to-time due to staff absences, heavy workload etc.
- Participate in self-inspections as co-auditor and/or auditee as may be required.
- Undertake any other duties or tasks directed by the Head of Commercial Quality.
- A Bachelor's degree in relevant scientific discipline, e.g., Chemistry, Pharmacy, Life Sciences etc.
- At least 2 years' experience in the Human Pharmaceutical, Veterinary Medicine, Medical Device, or Food Industries.
- Basic knowledge of the regulatory requirements for the pharmaceutical industry (human and/or veterinary medicines).
- Experience with QA IT platforms such as GoTrack (TrackWise).
- Intermediate level competency in core Microsoft Office applications, specifically Word, Excel, Power Point and Outlook.Effective planning and time management
Boehringer Ingelheim offers a competitive remuneration and industry-leading lifestyle benefits including health insurance and a free and confidential Employee Assistance Program.
We want the best to apply!
Boehringer Ingelheim is a global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and foster an inclusive environment which benefits our people, patients, and communities.
How to apply
If you would like to be part of this highly driven and successful team, please submit your CV and a covering letter addressing the key criteria above.
You must have the right to live and work in this location to be considered for this opportunity.
Thank you for taking the time to consider a career opportunity with Boehringer Ingelheim. As part of our efforts toward continuous process improvement, you may receive a short survey pertaining to this recruitment process. We really appreciate your honest feedback. Thank you.
It is Boehringer Ingelheim's policy not to accept speculative resumes from Agencies, unless the role has been released directly to the agency. If we require your assistance on any roles, we will contact you at the time.
Position Area
BI - Animal Health
Position Location
NSW - Sydney
Organisation
BI AH - Australia
Schedule
Part-time
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