QA Specialist

7 months ago

Sydney, Australia ABBVIE Full time

**The opportunity**

The QA Specialist plays a critical role in providing independent and comprehensive Commercial Quality support within the affiliate. This includes overseeing a wide range of quality system requirements associated with pharmaceutical products, medical devices, combination products, biologics, and cosmetics.

In this position, you will be responsible for various areas of support, such as Storage and Distribution, ensuring the execution of potential quality events and product shortage management. You will also be involved in Supplier Controls, conducting Product Quality Reviews, implementing Risk Management strategies, overseeing Agency inspections and internal audits, managing CAPA processes, and ensuring compliance with overall Quality Manual requirements.

Your primary objective will be to ensure that all product, process, and system-related quality activities within the affiliate, from the receipt of final product through distribution, are aligned with Corporate, governmental, and local regulations and requirements. By diligently adhering to these standards, you will guarantee the highest level of quality and compliance in all aspects of our business operations.

As the QA Specialist, you will utilize your expertise in quality assurance to identify and address any potential gaps or areas for improvement. By conducting thorough assessments and implementing robust quality control measures, you will contribute to the continuous enhancement of our quality management systems.

Collaboration with cross-functional teams will be essential in this role, as you work closely with various stakeholders to ensure a comprehensive approach to quality assurance. Through effective communication and collaboration, you will foster a culture of quality excellence and support the overall success of the affiliate.

Join us in this pivotal role, and together, we will uphold the highest standards of quality, compliance, and customer satisfaction, making a significant impact on the success of our organization

**Responsibilities**
- Maintain the Documentation Management System (eDMS) as the System Administrator for the Affiliate and support the JAPAC region as required.
- Act as System Administrator for the Quality eLearning Management System (eLMS)
- Ensure training curriculums are established and maintained within eLMS and regularly reviewed with cross-functional leaders.
- Integration of local quality regulations for drugs, biologics, devices, and/or combination products and cosmetics.
- Design effective quality systems, procedures and/or processes within cross-functional teams to ensure compliance as well as efficiency throughout our quality systems.
- Work on assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.
- Plan, prepare, review, and approve quality documentation such as change controls, product reviews and other local requirements.
- Support self-inspections, internal, external and MoH audits as directed by the manager.
- Coordinate and investigate quality events such as deviations, non-conformances and corresponding action plans including decisions.
- Monitor metrics and KPIs to ensure compliance.
- Support the Management Review process for the affiliate

**Preferred experience**
- Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire and OneVault.
- Excellent computer skills, including Microsoft Office and Visio
- Strong written and oral communication skills
- Good time management skills
- Full understanding of local GxP requirements including regulations and standards affecting device, biologics, pharmaceutical products and cosmetics.
- General knowledge and understanding of AbbVie MD, pharmaceutical, biologic and cosmetic products and regulations.
- Ability to support projects as a team member as assigned by manager.
- Experience working in both a team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
- Make decisions in collaboration with management.
- Acts as an owner - use available resources to independently complete assigned tasks.

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