This diversified business is a successful TGA/GMP licensed Pharmaceuticals Company who is well cemented in the Australian and Global markets.
The business compounds and dispenses the latest imaging and therapy agents from manufacturer's worldwide for use in Radiopharmacies, Oncology, PET Imaging and Medical Imaging Centres and also provides specialist manufacturing services.
About the role
Global Medical Solutions is currently looking for an experienced, motivated and cutting-edge Quality Assurance Technician to join the compliance division of our established team.
This position is a full time permanent position and will be based out of our Sydney office.
This role is well suited to a candidate who has 1-2 years' experience in the pharmaceutical industry working across quality assurance.
Your key responsibilities
Adhere to all aspects of cGMP as applied/adapted by GMS quality management system (QMS) and ensure stringent application of those principles across pharmacy operations.
Prepare, issue, and review batch records and other controlled documents
Review manufacturing records for compliance with GMP requirements
Assist with the implementation and maintenance of quality systems, documentation, training, batch records, complaint handling and reporting.
Liaise with external suppliers, consultants,



regulators and other agencies
Assist in ongoing training of the production team in aspects relating to cGMP
Assist with internal audits and external audits
Manage and investigate deviations, change controls and risk assessments
Assist with root cause investigations and implementation of CAPAs
Assist in product quality reviews
Assist in Product Recalls
Prepare reports including but not limited to, deviation, CAPA, investigations, and complaints
Perform release for supply of products
Assist with the incoming testing and release of starting materials
Assist with the development and implementation of QA process improvements
Work closely with production and compliance departments
Carry out other projects as directed by the Quality Assurance
Act as a delegate of the QA Manager in their absence
What you will bring
Tertiary qualification in science, biotechnology, healthcare or related disciplines
Experience in GMP and PIC/S requirements
Excellent attention to detail
Strong interpersonal and written and verbal communication skills
Ability to work in a dynamic, fast-paced environment
Ability to work in a rotating roster (including 05:00am starts)
#J-*****-Ljbffr

📌 Qa Technician (Sydney)
🏢 Global Medical Solutions
📍 Sydney