Management of CAPA from tracking, including follow-ups and closure.
Management of Change Control, Deviations, from tracking, follow-ups and closure.
Review quality process control plan, drive quality issues to root cause, corrective actions and improvements.
Perform, document internal audits and other quality assurance activities to ensure readiness on international standards certification audits and GMP inspection.
Coordinate and assists during customer visits and audits.
Create, review work instructions and standard operating procedures, devise sampling procedures and directions for recording and reporting quality data.
Review the implementation and efficiency of quality and inspection systems.
Collect, compile statistical quality data, and analyze data to identify areas for improvement in the quality system.
Review of analytical reports, and batch records (manufacturing and packaging)...