Quality Assurance Associate -18-month contract

Biopharma Asia; Sydney; Hybrid; AUD 70,000 - 90,000; Full time

Job summary

Biopharma Asia is seeking a Quality Assurance Associate on an 18-month contract to support Quality Systems & Compliance across Australia and New Zealand. You will execute tasks under the PQS to ensure regulatory compliance and assist the QS&C sub-team with non-transactional quality activities.

The ideal candidate holds a relevant science degree with 2–5 years of industry experience, comfort with QA documentation, and familiarity with QA IT platforms like TrackWise.

Qualifications

• Bachelor's degree in a relevant scientific discipline.
• 2–5 years’ experience in Human Pharmaceutical, Veterinary, Medical Device, or Food industries.
• Basic knowledge of pharmaceutical regulatory requirements.
• Intermediate MS Office skills (Word, Excel, PowerPoint, Outlook).
• Experience with QA IT platforms such as GoTrack (TrackWise).
• Experience with ERP systems, such as SAP.

Responsibilities

• Support local Supplier Lifecycle Management per local regulations and corporate requirements.
• Maintain quality system documentation (SOPs, Quality Agreements, Supplier Management).
• Raise/review deviations, investigations, CAPAs, QA risk management, and change controls.

Skills

Negotiation skills

MS Office proficiency

GMP awareness

Education

Bachelor's degree (Chemistry/Pharma/Life Sciences)

Tools

TrackWise/GoTrack

SAP ERP

Job description

The Position

Join our team as a Quality Assurance Associate on an 18-month contract, supporting Quality Systems & Compliance activities across Australia and New Zealand. In this role, 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 and 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 through verification of CAPA, 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, Quality Risk Management & 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
• Participate in self-inspections as co-auditor and/or auditee as may be required
• Maintain appropriate quality records as required by applicable procedures
• Provide support to product quality team as may be necessary from time-to-time for releases, complaints and returns
• Undertake any other duties or tasks directed by the Head of Commercial Quality

About our future employee

• Bachelor’s degree in relevant scientific discipline, e.g., Chemistry, Pharmacy, Life Sciences etc.
• At least 2-5 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).
• Intermediate level competency in core Microsoft Office applications, specifically Word, Excel, Power Point and Outlook.
• Experience with QA IT platforms such as GoTrack (TrackWise).
• Well-developed negotiation skills.
• GMP (Good Manufacturing Practice) training from a recognized training provider would be an advantage
• Experience with ERP systems, such as SAP, would be highly regarded