Microbiology Sterility Assurance Specialist
Partnering with a well established Pharma partner with over 60 years industry experience, I am looking for an experienced Sterility Assurance Specialist.
With the business refocusing on the Manufacturing of Sterile Injectables, they are looking to build out the Sterility Assurance Program. This role will offer independence and encourage a 'trial and error' approach to establishing procedures. If you are looking to join an ambitious organisation with clear growth plans both for you and the business, then this could be for you.
Are you passionate about ensuring product quality and compliance with regulatory standards? We’re seeking a skilled Microbiology Sterility Assurance Specialist to join our team. In this pivotal role, you’ll play an integral part in maintaining sterility assurance, supporting testing processes, and implementing contamination control strategies. Let’s dive into the details:
Purpose and Scope:
- Evaluate proposed manufacturing processes and associated controls to assess the potential introduction of microbial, endotoxin, and particulate contaminants.
- Provide expertise across all sterility assurance programs, including disinfectant evaluations, resident microflora assessments, airflow pattern testing, and environmental monitoring.
- Participate in internal and external audits, ensuring compliance with regulatory requirements.
- Apply quality improvement tools and techniques, addressing nonconformities, deviations, and barriers to improvement.
- Contribute to projects aimed at enhancing quality performance.
- Create, review, and approve technical documents related to sterility assurance.
- Risk Assessments: Lead or support risk assessments within the sterility assurance domain.
- Root Cause Investigations: Investigate and resolve issues related to sterility assurance.
- Floor-Level Compliance: Ensure adherence to environmental monitoring, aseptic process simulations, and other sterility assurance protocols on the manufacturing floor.
- Procedure Maintenance: Author and maintain quality system procedures, policies, and forms.
- Industry Alignment: Evaluate procedures for compliance with industry standards.
If you’re ready to make a difference in sterility assurance, join us! Let’s create a safer, cleaner world together.
