QA Technician

Global Medical Solutions; Sydney; On-site; AUD 65,000 - 85,000; Full time

Job summary

Global Medical Solutions in Sydney seeks an experienced Quality Assurance Technician to join the compliance division and help maintain cGMP standards across pharmacy operations. The role is full-time and based at our Sydney office.

Ideal candidates have 1–2 years of pharmaceutical QA experience, strong attention to detail, and the ability to work in a fast-paced environment with rotating rosters. Join our team to support batch records, QA processes, audits, deviations investigations, and CAPA

Qualifications

• Bachelor-level or higher in science, biotechnology or healthcare related field.
• Experience with GMP/PIC/S requirements and quality systems.
• Attention to detail and strong documentation habits.
• Excellent written and verbal communication.

Responsibilities

• Adhere to cGMP as applied by the QMS and ensure principles across operations.
• Prepare, issue, and review batch records and controlled documents.
• Review manufacturing records for GMP compliance.
• Assist with QA system implementation, documentation, training, CAPAs and audits.
• Investigate deviations, changes, and risk assessments; participate in CAPAs.
• Assist with product quality reviews and recalls as needed.

Skills

Attention to detail

Communication skills

Interpersonal skills

Fast-paced environment

Rotating roster

GMP experience

PIC/S knowledge

Education

Tertiary qualification in science/biotech/healthcare

Job description

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 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)