As the Quality Assurance Manager , you will be responsible for overseeing the overall administration of quality assurance in all manufacturing aspects of the company’s 212Pb-based API and radiopharmaceutical products.
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, there are opportunities to be part this high-performing team who are experts in their field.
This role will involve the effective implementation and maintenance of the Quality Management System (QMS), the overall management of batch record review, change control and investigations and ensuring efficient use of resources, implementing high standards of quality and safety while maintaining compliance with regulatory requirements and industry standards.
What are the benefits?
- Brand new role
- Competitive salary package + relocation support (if required)
- Gain valuable experience working under a range of quality and regulatory frameworks as the products evolve to commercialisation
- Culture of teamwork towards common goals
What will you be doing?
Overall administration of the Quality AssuranceDesign, monitor, effectively implement, maintain and update the Quality Management System (QMS) to ensure regulations are adhered to and industry best practices are referenced.Overall responsibility and timely management for batch record review, change control, investigations into deviations and execution of CAPAApprove or reject starting materials and packaging materialsParticipating in or initiating the company quality manualParticipation in management reviews of process performance, product quality and of the QMS and advocating continual improvement / quality by designDetermination of the standards for the ongoing GMP training of all employees as well as supervision of GMP complianceReview, evaluate and approve SOP’s and other GMP-related documentsResponsible for GMP training of functional areas and contributes to the development of appropriate GMP training for internal and external personnel.Oversee audit schedule, and execution of audit plans, reviews audit reports, and tracks corrective / preventive actions associated with vendors in accordance with applicable regulations, guidelines and SOPs.Ensuring compliance with the technical requirements or regulations of regulatory agencies related to the quality of finished productsWork closely with Production, Regulatory Affairs and other departments within the organisation to ensure compliance with regulatory requirements, including FDA, TGA, EMA and other relevant regulatory agencies throughout the product lifecycle.Maintain accurate production records and documentation, including inventory levels, batch records and associated reports, in accordance with cGMP requirements,Participate in the development and validation of manufacturing processes for new and existing radiopharmaceutical products by working closely with R&D and Regulatory Affairs teams.Participate in production planning meetings, providing input and insights to support strategic decision-making.Work closely with the production manager to implement changes to production and quality control processes, documentation, and process flows where required.Ensuring a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of managementImplement and reinforce practices that make safety an ongoing consideration for all operational activities leading to a safe and clean working environmentResponsible for developing department goals, objectives and systemsNote that this team performs some early morning starts and night shifts, however this position will be required to work Monday to Friday 9am – 5pm for most of the time.
What do you need?
Tertiary qualifications in chemistry, engineering, pharmaceutical sciences or relevant discipline.Minimum of 5 years of experience in quality management, preferably in the radiopharmaceutical industry.Strong technical knowledge of radiopharmaceutical manufacturing processes, equipment and quality control principles.In depth knowledge and understanding of cGMP regulations, TGA and FDA guidelines, and radiation safety regulations applicable to radiopharmaceutical manufacturing.Possess a good level of practical skill in the use and application of Microsoft Office packages, company specific software, QMS related systems and activities.Update and / or acquire the knowledge and skills to develop and implement new procedures and / or products whilst ensuring and maintaining QMS and compliance with the requirements of GMP.Demonstrated ability to work to timelines and in high pressure situations.Excellent communication skills and strong analytical problem-solving skills, with the ability to collaborate effectively across departments and communicate with stakeholders at all levels.Working in a team environment and adhering to principals of diversity and inclusion.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).
Apply now or, if you have any questions, please contact Christelle Capini at [email protected] .
At Fuse, we specialise in recruitment for the scientific and manufacturing industry, and actively source a variety of roles for a broad range of organisations. If you are looking for a new opportunity, we’d love to hear from you!
If you know someone looking for a job, refer them to us and we'll give you $500
if we find them a new role!SCR-christelle-capini
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