Sterility Assurance Officer

Sterility Assurance Officer

Location: Site based

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.

• 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 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

• 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

Seniority level: Associate

Employment type: Full-time

Job function: Science and Quality Assurance

Industries: Pharmaceutical Manufacturing and Biotechnology Research