Sterility Assurance Officer
7 days ago
Brighton
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 • Site based role