Teams at PCI Pharma Services

Perform batch and master batch record reviews, lot disposition, deviation/investigation and CAPA oversight, change control and risk assessments to ensure cGMP and regulatory compliance for clinical and commercial manufacturing. Provide QA guidance for investigations, training, process improvements, and inspection readiness.

Prepare and present clinical packaging and distribution proposals. Collaborate with SMEs, Sales, and Project Management to calculate material quantities and complex costing, draft proposals and change orders, lead meetings with internal teams and clients, develop project timelines, and ensure adherence to PCI, cGMP, and GCP. Use MS Office to manage and prioritize multiple requests and support transitions to project management.

Supervise and pace up to three pharmaceutical packaging lines per shift, ensuring efficient, high-quality runs. Perform in-process checks, enforce cGMP/GCP and SOPs, coordinate with Maintenance, QA and Warehouse, train packagers, monitor output, escalate issues, and maintain safety and housekeeping. Night shift with possible overtime.