Fuse Recruitment | Quality Assurance Manager
Vor 5 Tagen
Quality Assurance & Control (Science & Technology)
As the Quality Assurance Manager , you will play a key role in the overall management of the QMS.
Join a small team who collaborate together to enhance the performance of the QMS whilst working dynamically in a consistently growing organisation.
This is a Brisbane based position with relocation support on offer if required.
Who will you be working with?
Our client is a clinical stage radiopharmaceutical company developing treatments to significantly improve survival and quality of life for patients with cancer.
As they continue to make advancements in their product development and clinical phases, they are constantly improving their Quality Management Systems.
The Quality team are a small team who take a lot of pride in providing their expertise to the wider business, supporting the development of products, introduction of GMP manufacturing systems and progression of clinical trials.
What are the benefits?
Lead role – opportunity for your next step Competitive salary package + relocation support (if required) Career growth on offer Culture of teamwork towards common goals What will you be doing?
As the Quality Assurance Manager, you will bring your expertise to guide the small quality team to deliver on key timelines and ensure that products are manufactured to essential specifications, quality and regulatory requirements.
The manufacturing process focuses on two key elements – the manufacturing apparatus and the radiopharmaceutical API.
As such, each day brings variety as the processes are scaled up to ensure that critical clinical timelines are met.
As the company evolves from R&D production to commercial production, there will be a need to apply GMP guidelines to meet quality and regulatory requirements such as PIC/S, ICH, TGA and FDA.
Key tasks of this role include:
Lead all quality assurance initiatives supporting the manufacture of radiopharmaceutical APIs.
Design, monitor, effectively implement, maintain and update the Quality Management System (QMS) to ensure regulations are adhered to and industry best practices are referenced.
Oversee audit schedules and the execution of audit plans, reviews and audit reports.
Track corrective/preventive actions associated with vendors in accordance with applicable regulations, guidelines and SOPs.
Work closely with Production, Regulatory Affairs and other departments within the organisation to ensure compliance with QA/RA requirements, including FDA, TGA, EMA and other relevant regulatory agencies throughout the product lifecycle.
What do you need?
We are looking for candidates who have 3 – 5 years of experience in a leading Quality position within pharmaceuticals, radiopharmaceuticals, nuclear medicine and/or sterile injectables.
This is a fantastic opportunity to utilise your expertise whilst taking lead responsibility for the QMS.
As the organisation grows, you will grow in the role and have the opportunity for career development.
This company is at phase II clinical trials with an evolving Quality Management System to meet demands as the products progress through each stage.
As such, the QMS will mature over time so having an adaptable approach with an eagerness to grow and learn is essential.
Other key requirements of this role include:
A tertiary qualification in Radiopharmaceuticals, Nuclear Medicine or equivalent; Demonstrated experience designing, implementing and monitoring a Quality Management System to meet the requirements of PIC/S, TGA, FDA, GMP and/or EMA; Experience working with short shelf-life products (i.e.
24 hours or less) or an understanding of the manufacturing and supply chain processes involved to achieve quality products in a short timeframe; Excellent written and verbal communication skills with previous experience in technical writing for SOPs, manuals and other quality documentation; A proactive and adaptable approach to evolving product requirements.
Note that this role is working with radiation products in a safety controlled and regulated environment so you must be comfortable working in this environment and maintaining a Queensland Radiation Use Licence (provided by the company).
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