Reporting to the Executive Director, the Quality ISO Specialist is responsible for managing and maintaining the ISO 9001 certified Commercial Eyes Quality Management System (QMS) and for its operational efficiency and excellence. The role leads activities to ensure the integrity of the quality system is maintained and all employees are committed to a quality culture, which includes: document and record control, individual/group training processes, external audit participation, conducting internal audits, vendor assurance, client feedback and handling, and CAPA & deviations.
- Lead, drive & act as subject matter expert in QMS and provide support to the wider company.
- Ensure the development, implementation and maintenance of the QMS and that it meets the requirements of ISO 9001/2015 standard.
- Manage testing, validation, and implementation activities for QMS systems as required.
- Chair Quality Group meetings and ensure follow up and completion of actions.
- Draft, review and implement new documents or edit existing controlled documents within the Quality document control module.
- Manage the CAPA System – Initiate and review corrective preventive actions and deviations and support SME’s in delivering Corrective Action Plans.
- Manage and lead the company wide internal audit process.
- Manage client RFP, vendor assurance and due diligence requests.
- Ensure that Business audit ready, keeping all relevant QMS documents up to date.
- Business or Science degree.
- Proven record in systems development.
- Pharma experience desirable however not essential.
- Detailed knowledge of quality systems principles including quality and business excellence models (e.g. ISO 9001/2015).
- Experience conducting quality assessments and audits.
- Knowledge of and experience with QMS including documentation management.
- Project management, process development and organisational skills
- Demonstrated quality/continual improvement focus.
- Highly developed organisational and problem solving skills.
- Demonstrated aptitude for CRM and other computer software such as Microsoft Suite.
- Excellent written and oral communication skills including communication of scientific data.
- High level of attention to detail.
- Ability to prioritise work and use good judgment.
- Be part of an inclusive and diverse working environment.
- Be a member of a team who supports and cares for each other.
- Work for a company consistently delivering excellence.
- Deliver work that makes a difference to people’s lives through health.
- Commercial Eyes does not accept applications from recruitment agencies.
- To apply for this role you must be a permanent resident or citizen of Australia.
Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.
If you would like more information or would like to apply, email our People, Learning & Performance department at [email protected].