At a Glance
- Tasks: Ensure quality standards in pharmaceuticals and assist with compliance and audits.
- Company: Established TGA/GMP licensed Pharmaceuticals Company with a global presence.
- Benefits: Full-time permanent role with competitive salary and career growth opportunities.
- Other info: Fast-paced environment with opportunities for professional development.
- Why this job: Join a dynamic team making a real impact in healthcare and pharmaceuticals.
- Qualifications: 1-2 years experience in quality assurance and a relevant tertiary qualification.
The predicted salary is between 49500 - 60500 $ per year.
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 innovative 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 c GMP 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 c GMP
- 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)
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QA Technician in Sydney employer: Global Medical Solutions
Global Medical Solutions is an exceptional employer located in Keilor Park, VIC, dedicated to providing vital radiopharmaceuticals that support healthcare across Victoria. With a strong emphasis on safety and quality, employees enjoy a collaborative work culture that fosters growth and development, alongside the unique opportunity to contribute to patient care. The early start time allows for a focused work environment, ensuring that team members can take pride in their critical role within the healthcare supply chain.