Descripción
The Senior Packaging Technician is responsible for independently executing clinical packaging activities in compliance with internal specifications, Standard Operating Procedures (SOPs), batch records and applicable Good Manufacturing Practices (GMP)/ Good Documentation Practice (GDP) and Environmental Health and Safety (EHS) requirements. This role performs primary and secondary packaging, operates packaging and labelling systems, supports documentation and SAP transactions, coordinates routine technical tasks within assigned studies and serves as an experienced technical point of contact for day-to-day packaging activities. Key Responsibilities: 1. Clinical Packaging Operations • Performs primary packaging of clinical studies according to internal specifications, SOPs and batch records. • Performs secondary packaging of clinical studies according to internal specifications, SOPs and batch records. • Supplies ordered study material to the corresponding packaging rooms and prepares materials in accordance with the relevant SOPs. • Operates packaging and labelling systems in support of clinical packaging activities. 2. Technical Coordination • Trains and supports new technicians during onboarding and routine operations. • Performs administrative work related to packaging orders and clinical packaging activities. • Escalates problems directly to the supervisor or manager as required. • Coordinates the execution of bottle filling, labelling and packaging activities for clinical studies. • Oversees compliance-related aspects of packaging orders and serves as a technical point of contact for technicians assigned to individual studies. • Performs cleaning verification for equipment and rooms and completes final cleaning verification at study closeout. • Executes SAP transactions related to packaging activities. • Prepares GMP documentation, including required photographs, and creates batch notes or comments as applicable. • Reviews and coordinates Packaging Technicians’ a