Your Role

CSL are hiring a QA Associate to assure the appropriate quality of our pharmaceutical products across different Value Streams. You will ensure adherence to applicable CSL standards and procedures and manage the review and approval of related records, quality risk assessments, non-conformances, investigations, CAPAs, change controls and monitoring and continuous improvement of quality performance metrics.

The scope of the Value Streams incorporates Quality Control, Utilities, Fractionation, Bulk, Recombinant, Filling and support activities, Media fill activities, Visual Inspection and Packing and Logistics & Warehousing.

Your Responsibilities

· Oversee all production and support related activities to provide real time (GEMBA) and post event review of process steps

· Complete in-process checks, sampling and inspection

· Responsible for product quality and compliance partnering with all teams within the site value streams regarding product quality aspects using structured processes

· Perform QA review and approval of operational, processing and records to ensure regulatory compliance with Australian, EU and USA regulatory requirements

· Provide technical input to the process of deviation/events, trend reviews ensuring the data is reviewed to meet scheduled approval timelines

· Delivery of training as required including Deviation Management, Documentation Management and additional systems as applicable

Your Experience

· A minimum of a Bachelor Degree in Science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical science or equivalent qualification or experience.

· Minimum of three (3) years working in a similar role

· Experience in Operational pharmaceutical manufacturing and technical support

· Experience in Pharmaceutical Quality and compliance

· Capable of making quality decisions, with coaching from peers, based on risk and providing sound advice and justification

· Demonstrated ability to problem solve by applying advanced technical knowledge and experience

· Customer focussed - Able to negotiate outcomes and a demonstrated ability to drive activity in a positive, proactive and timely manner