The GMP Operations Specialist at Haleon is a pivotal role that provides operational support to technical project teams, particularly within the Richmond Pilot Plant and Global Scale Up initiatives. This position encompasses a wide range of responsibilities, including general material handling, equipment assembly, operation, cleaning, maintenance, and the creation and execution of batch records and protocols. The specialist will also support Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) activities, and cleaning validation processes. The role requires close collaboration with the Pilot Plant Lead and the extended team to effectively execute project-related scale-up activities. Depending on the individual's level of experience, they may also assist in overseeing qualification protocols related to both process and cleaning activities. In this role, the GMP Operations Specialist will prepare and execute life cycle activities for equipment and systems within the GMP pilot plant, which includes specification, purchasing, and qualification processes. They will coordinate training activities for operators and scientists in the pilot plant, providing technical leadership and support during product manufacturing. The specialist will also troubleshoot and provide technical support for all equipment and systems, interfacing with external vendors for equipment demonstrations and repairs. Ensuring compliance with written procedures related to quality, safety, and methods is crucial, as is the identification and development of new procedures to enhance operational efficiency. The specialist will also support safety and quality responsibilities, ensuring adherence to GMP standards and conducting risk assessments for pilot plant activities. The role emphasizes a growth mindset, encouraging the specialist to identify their training needs and develop a training plan in collaboration with the Pilot Plant Lead. They will also be responsible for training themselves and others in new technologies and laboratory responsibilities, while building relationships with cross-functional partners to achieve shared goals. A data-driven approach is essential, ensuring that all work is conducted in accordance with current Good Distribution Practices (cGDPs) and current Good Manufacturing Practices (cGXPs). The specialist will take responsibility for specific equipment and may lead problem-solving initiatives as needed.