· Provide technical oversight of manufacturing, laboratory, storage and technical operations within the scope of responsibility.
· Review and provide technical input on specifications, master formulas, manufacturing instructions and technical documentation.
· Coordinate and support qualification, validation, calibration, preventive maintenance and technical change-control activities.
· Review technical aspects of deviations, CAPA, complaints, recalls, change controls and risk assessments.
· Coordinate with QA, QC, Production, Warehouse and Engineering to resolve technical and quality-related issues.
· Support regulatory submissions, product registration, licensing and technical communication with competent authorities as assigned.
· Support internal audits, regulatory inspections, supplier qualification and technical assessments.
· Ensure technical personnel receive appropriate training and that technical records are maintained.
· Monitor critical utilities, equipment and technical systems and coordinate corrective actions when required.
· Provide management with technical risk assessments, recommendations and reports.
· Support product release/disposition processes within the limits of the person's legal authority and the company's approved quality system.
· Promote patient safety, product quality, data integrity and compliance in all technical decisions.