Overview
Quality Assurance Manager Jobs in Perth, Western Australia, Australia at Proclinical Staffing
Title: Quality Assurance Manager
Company: Proclinical Staffing
Location: Perth, Western Australia, Australia
Proclinical is proud to be partnered with our client in the search for a Quality Assurance Manager to join their team.
Position: Quality Assurance Manager
Location: Perth, WA
Job Type: Full-time
Position Summary:
Our client is well established and fast moving radiopharmaceutical manufacturing facility. The Quality Assurance Manager will develop, execute, and maintain all quality-related activities. This role involves engaging and liaising with the Therapeutic Goods Administration (TGA) regarding all aspects of Good Manufacturing Practice (GMP). You will be part of a highly professional, interdependent team producing radiopharmaceuticals for clinical imaging, treatment, and research applications.
Key Accountabilities:
Ensure the quality of manufactured radiopharmaceuticals meets GMP standards.
Develop, implement, and maintain a Pharmaceutical Quality System (PQS) inclusive of Quality practices.
Manage a Quality Risk Assessment program.
Provide GMP training to personnel involved in manufacturing, quality control, and distribution activities.
Foster a culture of quality awareness and continuous improvement.
Provide leadership to ensure all roles with production and quality responsibilities are sufficiently skilled in cGMP.
Develop and conduct GMP-related training and compliance systems.
Establish meaningful Site Performance metrics and systems for monitoring results.
Manage ongoing licencing and internal and external audit inspections by regulatory agencies.
Role Requirements:
Degree-qualified in Science
5+ years of working experience in GMP pharmaceutical manufacturing.
Demonstrable knowledge of cGMP, TGA and Regulatory requirements for Australia.
Experience in internal and external audits.
Excellent leadership and communication skills.
Knowledge of radioactive materials handling, ALARA concepts, and Radiation Safety principles. (highly regarded)
Application Process:
If you meet the above requirements and are ready to take on this exciting challenge, please submit your resume and optional cover letter detailing your relevant experience and why you are the ideal candidate for this role.
For further information, please contact Pamela Phoumavong on 02 9054 7411 or email [email protected].
About Proclinical
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, bio-pharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
https://www.proclinical.com/
