QUALTY VALIDATION ASSOCIATE
- Opportunity to join an Australian leader in Medicinal Cannabis in Mildura, Victoria – Australia
- Grow your career in Quality Validation
- Newly created position > Join a High Performing Team
Cann Group Limited (“CANN”) is the first Australian Company (ASX: CAN) to secure the necessary licenses and permits to cultivate cannabis for medicinal and research purposes under the Australian Government’s new medicinal cannabis regulatory system. CANN’s objective is to be a leader in the medicinal cannabis industry. CANN’s licenses and permits allow for breeding plants for propagation purposes, research and development of unique cannabis extracts, and the supply of plant material for manufacturing into medicinal cannabis for patient use.
We are searching for an experienced Quality Validation Associate to join our Quality team in Mildura, Victoria, Australia.
POSITION SUMMARY
With a strong customer focus, this position requires supporting, reviewing and facilitating the completion of validation tasks within the company. This role supports the completion of quality objectives and supports tasks which ensure the Medicinal Cannabis products produced and supplied to customers is appropriately validated consistently met quality, safety and efficacy. As an active participant in the delivery of all CANN products and their respective product life cycles, this position ensures that quality is built into processes and day to day operations, driving a quality culture through all levels of the business that ultimately delivers quality product.
This position is an advocate for continuous improvement and drives processes that ensure the suitability, effective implementation, monitoring (for effectiveness) and maintenance of a compliant quality management system at CANN. Further, supports ongoing compliance to GxP (i.e. Good Manufacturing Practice, Good Laboratory Practice, Good Distribution Practice etc), GACP and controlled drug substance requirements – to Australian standards (e.g. Therapeutic Goods Administration – Manufacturing and Office of Drug Control and Department of Agriculture and Water Resources) and all other applicable international legislation and health authority requirements.
As with all CANN employees, this position must endeavor to demonstrate all CANN values and will promote CANN values and beliefs to all areas and levels of the business.
KEY RESPONSIBILITIES AND ACCOUNTABILITIES
- Completes tasks to deliver the Quality validation portfolio including the validation master plan and associated validation framework;
- Acts an advisor in all Quality Validation related activities and responsibilities and further, promotes practices to achieve quality outcomes;
- Supports the validation activities as part of facility design, build and qualification and is the point of contact for 3rd party manufacturing with respect to validation;
- Supports the overall validation life-cycle at CANN;
- Execution of validation protocols and creation of validation reports;
- Supports Quality and business goals;
- Reviews and approves plans for validation testing and verifies that testing has been performed, with all associated records evaluated;
- Ensure systems are in place to control the validation life-cycle from raw materials (packaging, labels, intermediates) to finished products (where required);
- Acts as technical expert and executes validation processes to ensure completion and compliance;
- Reviews and maintains training including initial and ongoing;
- Monitoring and compliance with the requirements of GxP and controlled drug substance requirements – to local (i.e. Therapeutic Goods Administration – Manufacturing, Office of Drug Control, and DAWR), international legislation and health authority requirements;
- Supports management reviews of validation process performance and advocate for continuous improvement.
PERSON SPECIFICATION
Qualifications / Licences
- Tertiary qualifications in Science, Engineering, or equivalent.
- Current Driver’s Licence (Australian)
- Police clearance (Commonwealth)
Experience
- At least 5 years’ experience within a Validation/Quality Assurance role in a Pharmaceutical / Biopharmaceutical manufacturing environment;
- Demonstrated experience with enabling technology / automation in production/manufacturing environments ;
- Working knowledge of the Australian regulatory requirements (TGA Code of GMP, PIC/S and Narcotic Drugs Act (preferable);
- Demonstrated experience in performing validation execution and report writing;
- Demonstrated track record of providing workable solutions to complex business challenges in a fast paced, emergent business.
Skills / Competencies
- Fundamental understanding of validation principles.
- Working knowledge of diverse business functions and principles (e.g. supply chain, manufacturing etc.)
- Demonstrated ability to generate respect and trust from employees and external constituencies.
- Demonstrated ability to perform with a high degree of professionalism, integrity and business ethics.
- Strong communication/facilitation skills, both written and verbal.
- Strong analytical and problem-solving skills.
- Strong relationship management skills; coaching skills.
- Strong results orientation.
- Strong analytic skills.
- High attention to detail.
If you believe your skills and experience meet the above criteria, and you want to take the next step in your career in a supportive and innovative environment, click apply today.
Please note only applications with the right to live and work in Australia will be considered for this position. The successful applicant will be required to undergo a National Police Check.
