Teams at Inteldot

Supports pharmaceutical manufacturing facility quality systems, including deviations, CAPAs, change controls, documentation updates, and OEFM electronic forms. Investigates deviations, maintains inspection-ready records, evaluates facility and utility changes, and collaborates with Quality and engineering stakeholders. Also supports pest control program modernization, vendor coordination, validation documentation, regulatory compliance, and technical troubleshooting for HVAC, chilled water, and cooling tower systems.

Supports manufacturing and quality systems, including procedures, document control, process monitoring, non-conformances, CAPA, troubleshooting, training, process validation, regulatory inspections, new product introductions, and process or equipment modifications. Evaluates manufacturing performance, authors investigations, manages corrective actions, analyzes trends and validation data, and provides project management support for process improvements.

Support the Quality Assurance program through batch record review, GMP/GDP documentation review, SAP inventory activities, electronic batch record assessment, quality event evaluation, risk-based decision-making, and regulatory compliance. The role collaborates with Manufacturing, Quality, Supply Chain, and Warehouse teams, communicates risks and pending activities, participates in operational meetings, and independently manages quality responsibilities with minimal supervision.