Manufacturing Batch Reviewer I

Manufacturing Batch Reviewer I Location: Edinburgh BioQuarter, Little France Who are we? We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives. Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science. Find out more about what we do here ! Due to the nature and training requirements of this role, applicants must have the legal right to work in the UK with sufficient permission to meet the needs of the position. We are unable to provide visa sponsorship for this role under the Home Office restrictions. Why join us? The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career A generous salary package – we reward our people at the level they deserve 31 days of annual leave, plus 4 public holidays which increases with tenure A competitive company pension scheme to help you save for the future Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us Flexible benefits such as retail discounts and access to the Cycle2Work scheme. Your new role An exciting opportunity to join the Manufacturing Batch Review Team (MBRT) as a Manufacturing Batch Reviewer I . Review executed manufacturing batch documentation (batch records, in-process data and environmental monitoring data) to ensure GMP compliance and adherence to operational SOPs. Investigate and impact assess technical problems identified during reviews, collaborating with Manufacturing and Quality departments. Assure timely communication of quality events identified during document audit with relevant departments, including raising deviations. Generate environmental monitoring reports investigating any discrepancies. Input manufacturing batch data into an analytical software programme for continued process verification (CPV). Provide regular feedback on findings during document review to relevant departments as appropriate. Evaluate trends and work pro-actively and collaboratively on improvement initiatives to reduce data errors and deviations. Work to ensure timely closure of packs for batch disposition and shipment to patient by working collaboratively with relevant departments. Assist in training and coaching relevant personnel to develop their GMP recording, review and technical writing skills. Attend MBRT meetings to provide appropriate feedback in respect status and progression of manufacturing documentation. Input batch-related data into Manufacturing and QA batch review trackers where applicable. Support with daily MBRT housekeeping activities,…