Microbiology Quality Manager, Pharma, Sterile Manufacturing
Evolve Scientific Recruitment
About the company:
Our client is a sterile radiopharmaceuticals manufacturer based in South Sydney. Utilise your drive and initiative to succeed in this role and to progress your career within this government organisation, which dominates the market in its field and is currently expanding into the global market.
About the Role:
Evolve Scientific Recruitment is seeking an experienced Microbiology Quality Manager for this sterile manufacturing facility. Leadership experience and a proven track record in sterile manufacturing with a strong regulatory and compliance focus is essential.
The Microbiology Quality Manager is responsible for leading the Microbiology team to ensure manufacturing and microbiological testing is executed in the production facility and carried out as per current GMP guidelines, you will also have a commitment to continuous improvement.
Your responsibilities will include:
- Liaising closely with key stakeholders across the business ensuring the smooth running of the lab, leading the team, analysing results, preparing reports
- Manage all aspects of microbiological testing for starting materials, intermediate materials and finished products. Make recommendations on the microbial quality of the finished products, intermediates and raw materials and risk to product quality.
- Develop and implement strategies that comply with the overall goals of the business i.e. in regulatory and technology developments
- Ensure all procedures are conducted in the correct manner in accordance with SOP’s and accreditation requirements - TGA, FDA and GMP
- Act as a subject matter expert to assist with compliance and regulatory requirements
- Train, coach and develop staff to ensure technical knowledge is shared across the quality team. Provide advice and guidance on ways of developing the skills and experience of others.
- Maintaining all aspects of the Quality Management System relevant to the laboratory activities
Skills & Experience:
- Tertiary qualifications in Science with a strong focus on Microbiology and relevant professional experience
- Management/supervisory experience in an industry laboratory in the area of Microbiology ideally within sterile manufacturing and/or sterility assurance or a manufacturing operation of equivalent complexity
- High level technical experience in microbiology testing procedures and an understanding of testing requirements
- In depth knowledge of and demonstrated ability to apply the various Codes of GMP for Medicinal Products especially Annex 1, EU Guidelines, BP, EP, USP, FDA, ISO 9001, ISO 14644
- Excellent communication skills and a high attention to detail, with high level written, oral and interpersonal skills
- Demonstrated ability to work as part of a team, problem solve and apply sound judgement in quickly responding to new opportunities and challenges.
- Excellent organisational and project management skills and proven ability to be self-directed to meet tight deadlines, prioritise tasks and effectively maintain budgets
How to Apply:
Click on the "Apply Now" button with a cover letter addressing the selection criteria above AND a detailed resume in WORD format (PDFs can be corrupted / not processed). Note: Applications only accepted from Australian citizens.
How to Register with Evolve:
For upcoming positions please click on the "Apply Now” button. By applying to any of our roles you will also be registered for future positions unless you request not to be.
Why Evolve Scientific Recruitment?
Evolve is an award winning agency specialising in scientific/technical recruitment in: Pharmaceutical, Food, Biotechnology, Chemical, Petrochemical, Environmental, Health Services, Life Sciences, Mining and more.
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