Alfred Health
Alfred Health is a leader in health care delivery, improvement, research and education. We are the main provider of health services to people living in the inner southeast suburbs of Melbourne, from ambulatory to inpatient and home and community-based services.
- Fixed Term Appointment (12 Months) - 15 Hours Per Fortnight
- Medical Scientist Grade 1 Year 1-7
- The Alfred location
- Salary Packaging & Novated Leasing Available
About the Role
The Skin Bioengineering Laboratory, is an integral part of VABS. The Quality Nominee will ensure a high standard of quality is maintained in clinical research and / or product manufacturing activities. The Quality Nominee will ensure that all activities of the laboratory, where applicable, are in compliance with the Australian Code of GMP - Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products.
- To comply with all policies and procedures of the unit.
- To provide quality management for the running of the Skin Culture Laboratory;
- To carry out internal reviews and audits
- To ensure quality assurance of production, documentation control and validation of procedures;
- To ensure that the required initial and continuing training of production personnel is carried out;
- To ensure that facilities and equipment are maintained and that the appropriate validations are carried out;
- To approve or reject, as appropriate, materials and therapeutic products;
- To evaluate process records and ensure that all necessary testing is carried out;
- To approve specifications, sampling instructions, test methods and other quality procedures;
- To approve and monitor any subcontractors and suppliers;
- To review all non-conformances / deviations and to ensure agreed actions have been carried
Skills & Experience
Essential
- Tertiary qualification in Science, Life science, Pharmacy or other relevant disciplines • At least 2 years’ experience in a Pharmaceutical or medical device manufacturing environment
- Demonstrated understanding of the TGA Code of GMP
- Demonstrated knowledge and understanding of Medical Device, Cell and Tissue Quality (i.e. document management, batch release, audits, change control etc), equipment and method validation, sample preparation, analytical techniques & data management
Desirable
- Experience in clinical Trials
Benefits
- Salary Packaging & Novated Leasing through Maxxia.
- Flexible Heath Insurance coverage through HCF Health Insurance
- On-site car & bike parking opportunities, Deducted Pre-Tax!!
- Fantastic onsite fitness facilities at The Alfred through ProSport Health and Fitness.
- Child Care Services at The Alfred managed by KU Children’s Services
All enquires to Dr Shiva Akbarzadeh on [email protected]
Applications Close: 11pm AEST, Tuesday 21st of May 2024
Alfred Health is an equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve. Applications from Aboriginal and Torres Strait Islanders are encouraged.
In accordance with the Health Minister's Covid-19 Mandatory Vaccination Order, all Alfred Health employees are required to be fully vaccinated (3 doses) for COVID-19 or hold an acceptable medical exemption. Furthermore, in accordance with the Health Services Amendment (Mandatory Vaccination of Healthcare Workers) Act 2020, health care workers in Category A or B roles (as determined by the department’s risk ratings) are required to be vaccinated against influenza or hold an acceptable medical exemption.
Website: www.alfredhealth.org.au