Quality Assurance Associate (12-month contract)
The Position
Product Quality is that part of Commercial Quality whose primary focus is on transactional tasks i.e., release-for-distribution, customer complaints, assessment of market returns etc. The focus of this position will initially be release-for-distribution.
Tasks & Responsibilities
- Perform release-for-distribution activities, including liaising with manufacturing sites, external warehouses, supply chain, and regulatory affairs.
- Use the GoTrack (Trackwise) system to raise quality records such as Deviations, Events, CAPAs, Change Control, Quality Risk Management, etc., as per approved procedures.
- Report on release performance (i.e., KPIs) at the quarterly Quality Management Review.
- Process Technical Product Complaints in the GoTrack system and in accordance with relevant standard operating procedures (SOPs) as may be required due to staff absences or workload.
- Process market returns as per local procedures and timelines as may be required due to staff absences or workload. Liaise with Customer Service as necessary to obtain all required information.
- Participate in the development and implementation of local quality-related processes and procedures, ensuring compliance with applicable local regulations and Corporate requirements.
- Maintain appropriate quality records as required by applicable procedures.
- Participate in self-inspections as may be required.
- Undertake any other duties or tasks directed by the Head of Commercial Quality.
Requirements
- Relevant scientific degree e.g. Chemistry, Pharmacy, Life Sciences etc.
- At least 2 years’ experience in the Human Pharmaceutical or Veterinary Medicine industries
- Experience with QA IT platforms such as GoTrack (TrackWise)
- Knowledge of the regulatory requirements for the pharmaceutical industry (human and/or veterinary medicines)
- Intermediate to advanced level in core Microsoft packages, particularly Word, Excel, Power Point and Outlook.
- Experience with ERP systems e.g. SAP
- Previous experience performing Quality audits
- Pharmaceutical/veterinary medicine manufacture
Why Boehringer Ingelheim?
Our workplace is a creative and dynamic place to be – with the future always on our minds. Your personal journey is one you can develop from the very start, with leadership that nurtures your ambition with you.
Boehringer Ingelheim offers a competitive remuneration, attractive bonus scheme, subsided health insurance, employee assistance program, development programs and career development opportunities.
Our people are the beating heart of Boehringer Ingelheim and we have been recognised as a global Top Employer for five years. We value diversity by embracing various perspectives, fostering an inclusive environment that benefits our people, patients, and communities.
What’s next? - How to apply
If you would like to be part of this highly driven and successful team, please submit your CV addressing the key criteria above.
You must have the right to live and work in this location to be considered for this opportunity.
It is our policy not to accept speculative resumes from recruitment agencies.
Position Area
Group Functions
Position Location
NSW
Organization
Boehringer Ingelheim
Schedule
Full Time
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