Sun Pharmaceuticals (Australia) is a stand-alone operation that supplies up to 25% of the global demand for opiate raw materials and active pharmaceutical ingredients to the global pharmaceutical industry.
It has achieved market share leadership through quality, offering an extensive product range, customer responsiveness, high capacity and capability manufacturing and cropping operations coupled with innovations brought to the market through R&D.
Sun Pharmaceutical's supply chain is focused at two sites in Australia and starts with agricultural operations in Tasmania that cultivate, harvest and process poppy crops, through to highly regulated extraction and value adding manufacturing operations in Victoria.
We are seeking a suitably skilled and experienced person to join our quality assurance team at our Port Fairy site in an important leadership position.
Key Duties
* Provide quality and compliance oversight for operational quality, batch release and quality systems for API and related intermediate products.
* Manage and/or oversee quality alert processes, batch release, deviation investigations, quality risk management and compliance decision making for API and related intermediate products.
* Accountability for external audit management, quality risk management, global action items and TrackWise.
* Support hosting of regulatory inspections, corporate quality and customer audits.
* Manage CAPA closure and support responding to customer regulatory & quality enquiries.
Desirable skills/knowledge/experience
* Bachelor Degree in Quality, Science or Engineering.
* Previous experience (5+ years) in a quality management role within the pharmaceutical (or related) industry.
* Strong understanding of TGA & EU Regulatory GMP requirements and industry best practice for the implementation of quality systems.
* Direct experience implementing, managing and improving key quality systems and the management of quality records.
* Sound, pragmatic and prompt decision making capability when confronted with complex issues.
An attractive remuneration packages will be offered to the successful candidates.