Descripción
The Specialist, Packaging Compliance Support, is responsible for supporting packaging compliance activities across batch record preparation and review, investigations, documentation, training support, and operational coordination. This role helps ensure that packaging support processes are executed in alignment with SOPs and applicable GMP, GDP, and EHS requirements, while supporting compliance-related operational topics and cross-functional collaboration within the assigned area. Responsibilities: 1. General Packaging Support • Investigates Clinical Complaints (CFAIs) within Packaging Area. • Conducts investigations related to compliance topics, SAP Quality Notifications, and Corrective and Preventive Actions. • Manages SOP updates, including attachments and wall documents. • Performs pre-execution review and preparation of required batch record documents according to SOPs. • Conducts post-execution review of batch records and supporting documentation according to SOPs. • Supports training activities, including curriculum updates and training plans. • Schedules and coordinates tasks and activities within the area of responsibility. • Serves as a knowledgeable point of contact for assigned work centers. • Resolves operational issues and addresses SAP-related issues. • Participates in cross-functional meetings as needed. • Manages archiving activities. • Supports packaging execution 2. Compliance & Safety • Adheres to dress code and GMP area access requirements. • Follows proper gowning procedures and personal protective equipment requirements. • Supports GMP compliance activities within the area of responsibility. • Identifies factors that could lead to unblinding. • Completes all required training before performing assigned tasks. • Uses the facility environmental monitoring system where applicable. • Identifies and reports safety issues. • Supports GDP corrections on behalf of the Head of Packaging Operations, as assigned. • Reviews monthly nRFT submissions and re