Sterility Assurance Officer
Location: Site based
Position Summary
We are seeking a Sterility Assurance Officer to provide expert sterility assurance guidance across manufacturing, production and engineering operations at two sterile manufacturing facilities. This role plays a key part in promoting strong aseptic behaviours, supporting GMP compliance, and driving continuous improvement within sterile operations, including support for IMP manufacture.
Key Responsibilities
* Promote and support compliance with GMP and GDP in line with current regulations and internal quality standards
* Provide sterility assurance support for manufacturing, production and engineering activities
* Carry out compliance spot checks in operational areas, including CCTV review where applicable
* Train, support and raise standards around aseptic behaviours within sterile operations
* Champion good aseptic practices essential for the manufacture of sterile pharmaceutical products
* Lead and support non conformance, complaint and OOX investigations, including GEMBA activities and report writing
* Support CAPA and change control actions
* Contribute to risk assessments and quality risk management activities
* Support and drive improvements to the site sterility assurance programme
* Compile and present environmental monitoring trend data across relevant forums
* Support self inspections and internal audits within the operational areas
* Share quality metrics relevant to sterile manufacturing activities
* Support shutdowns, new equipment introductions and validation activities, providing GxP and sterility assurance guidance
* Effectively prioritise and manage workload to meet operational and customer requirements
* Support the maintenance of up-to-date training records across the site
* Maintain current knowledge of industry best practice and regulatory expectations
* Apply good manufacturing principles across all areas of responsibility
* Comply with company policies, procedures, health and safety requirements, and the code of conduct
Minimum Qualifications and Experience
* Minimum of 3 years experience within pharmaceutical manufacturing, testing or quality assurance
* At least 2 years experience working in a sterile manufacturing environment
* Experience leading or contributing to quality improvement initiatives
* Strong understanding of GxP regulations and guidance
* Excellent written and verbal communication skills
* Strong stakeholder management skills with the ability to build credibility and influence
* Competent in Microsoft Word and Excel, including data handling and reporting
* Strong report writing capability
Preferred Qualifications and Experience
* Relevant scientific degree
* Strong scientific and technical understanding of sterile and aseptic manufacturing
* Experience with sterility assurance controls and contamination control strategies
* Familiarity with electronic quality management systems
* Strong organisational skills with high attention to detail
* Ability to work effectively both independently and as part of a team
Work Conditions
Seniority level: Associate
Employment type: Full-time
Job function: Science and Quality Assurance
Industries: Pharmaceutical Manufacturing and Biotechnology Research
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