AddressWe are an Australian-owned and operated pharmaceutical company with a strong portfolio of pharmaceuticals products. Our facility is a state-of-the-art TGA licensed site with the potential for further expansion in the future. We are now seeking a highly skilled and driven Quality Manager to work with the rest of the team and lead the way with internal and external quality systems and processes.
With energy and skill, you will be responsible for managing the organisation's Quality Management Systems, ensuring that company products and processes adhere to TGA/FDA guidelines and other relevant regulations.
The successful candidate will possess the following credentials:
Tertiary qualifications in science or a related discipline.
Prior quality assurance experience within the pharmaceutical industry.
Previous experience with TGA, FDA, and ISO audits.
Strong knowledge of GMP regulations, quality management systems, and validation principles.
Develop and maintain the validation master plan for the GMP facility, encompassing equipment, processes, and systems.
Development and execution of validation protocols and reports, such as IQ, OQ, and PQ.
Strong knowledge of GMP regulations, quality management systems, and validation principles.
Conduct routine internal and external audits to verify compliance with quality standards and regulatory requirements.
Identify and rectify quality issues through root cause analysis, deviations, and CAPA (corrective and preventive actions).
A high level of drive, strong attention to detail, enthusiasm, and a ‘can do’ approach to work. Comfortable working in a fast-paced, rapidly changing environment; a willingness to learn and to seek answers to problems and issues and propose solutions.
Making and implementing recommendations for improvement.
Create training materials, SOP’s, batch documentation and procedures.
Good communication skills, both verbal and written.
Excellent data collection and analysis skills.
To express your interest in this role, please forward your CV and detailed cover letter APPLY NOW
