Senior Auditor, Supplier Quaiityオーストラリア, 香港R-0511303030 CSL Behring Asia Pacific
Starting a century ago, CSL made a promise to save lives and protect the health of people stricken with a range of serious and chronic medical conditions. Today that same promise has never been stronger.
With operations in more than 30 nations and over 14,000 employees worldwide, we develop and deliver biotherapies to prevent and treat people with life‐threatening medical conditions. Our broad‐range of therapies include those to treat disorders such as haemophilia and primary immune deficiencies, and vaccines to prevent influenza.
We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge, and support future medical research. Our world‐class commercial operation, combined with a large and focused R&D team and operational excellence, enable us to accurately identify, successfully develop, and dependably deliver innovations that patients and providers want.
For a century, CSL has earned a reputation as a passionate yet responsible organisation, driven to care for patients and deliver on its commitments.
Reporting to the Senior Manager Regional Supplier Quality you will be responsible for auditing CSL’s suppliers of plasma, materials and services. You will audit both current and potential suppliers to CSL to ensure adherence to CSL policies and procedures, regulatory frameworks and industry best practice guidelines.
This will involve significant travel which comprises around 50-70% of the role that will see you involved in physical on site auditing of suppliers and other times desk based paper audits. Internally you will be highly collaborative with Sourcing, Quality and Manufacturing Teams as well as and other internal stakeholders.
Your responsibilities will include but not be limited to:
- Routine travel to perform quality systems audits of approved and or potential suppliers of raw materials, components, suppliers and service providers for the CSL Sites. May also perform local site audits as requested.
- Prepares audit report and assigns levels of compliance to each observe action based on established criteria. Delivers audit results to suppliers in a professional manner. Evaluates supplier corrective action plans are satisfactorily addressing the observation(s).
- Responsible for interpreting and making decisions based on company policies/procedures, regulatory agencies, local, state, federal and international regulations.
- Responsible for supplier quality agreements, global and local, which include writing, editing, reviewing, updating and routing the agreements for approvals between CSL Manufacturing Site, service providers and suppliers.
- Assist the Manufacturing Site as the subject matter expert for Supplier Quality during inspections to mitigate compliance risk to the manufacturing site and to Supplier Quality.
- In collaboration with Sr. Manager, Regional Supplier Quality, develop individual development plan which cultivates individual and organizational bench-strength.
To be considered for this position:
- Tertiary qualification in relevant business or science field or equivalent education and experience.
- Minimum 5 years worth of experience in a GXP environment.
- Healthcare experience would be strongly preferred but food or chemicals manufacturing industry experience also strongly regarded.
- You must have had previous supplier auditing experience within a GxP Manufacturing environment.
Apply now for a role with a varied remit in an organisation that is going through considerable investment and change.