Operations Specialist
- Support the Operations team with quality and compliance activities under the site's Quality Management System and cGMP requirements.
- Manage deviations, complaints, equipment reviews, root cause analysis, CAPA and trend assessments, including preparing clear reports.
- Coach Operations staff and contribute to continuous improvement initiatives in a GMP-regulated manufacturing environment.
About the company/role:
Our client is a leading global pharmaceutical manufacturer located in Brisbane’s western suburbs. They are currently seeking an Operations Specialist to join their Operations Support Team on a temporary full time casual contract
In this role, you’ll play a key part in supporting the Operations team to achieve compliance objectives by working within the site’s Quality Management System (QMS). You will be responsible for managing deviations, complaints, periodic equipment reviews, and other quality and compliance tasks. You’ll also coach and support Operations staff to enhance their understanding and execution of compliance activities, contributing to ongoing improvements in operational quality and performance.
Important: This role requires the successful candidate to complete a full medical assessment, drug screening, and police check prior to commencement.
Duties:
- Provide training, guidance, and support to the Operations team in managing deviations, conducting root cause analysis, report writing, CAPA, trend assessments, and other compliance-related tasks.
- Prepare clear, concise, and factual reports that analyse issues or trends, and propose corrective and preventative actions.
- Ensure compliance with cGMP by adhering to company policies and procedures.
- Identify and contribute to continuous improvement initiatives, particularly those focused on quality and compliance.
- Manage your workload efficiently and cost-effectively to meet operational goals and timelines.
Skills/experience:
- Bachelor’s degree in a scientific discipline.
- Experience working in a GMP-regulated environment.
- Exposure to lean manufacturing or continuous improvement methodologies.
- Background in a regulated Quality Assurance function.
- Prior experience in the pharmaceutical industry is highly desirable.
Apply!
If you think this could be the role for you then please apply now! Please send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted / not processed).
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