Develop and implement the Quality Systems of the Company for plant & products.
Would be responsible for facing USFDA, MHRA, WHO-Ganeva and semi-regulatory audits.
Plan and provide support to manufacturing activities as per Quality Management Systems (QMS) / GMP guidelines.
Establish effective plans, quality systems & procedures to assure compliance with all applicable regulatory bodies.
Technical investigations, assessment of non-conformances and its management by CAPA.
Plan and execution of manufacturing and analytical technology transfer activities.
Implementation of validated Training software (TRIMS) in all sites.
Identify training needs of quality teams; Conduct GMP, GLP and other training programs for employees across levels and functions.
Provide strategic guidance to the teams which are responsible for dossier preparation / submissions, product approvals & registrations, compliance with policies and norms.
Market complaints Investigation, CAPA analysis, resolution of complaints & taking timely corrective action.
Root cause analysis using fish Bone analysis and risk analysis by using FMEA, FTA tools
Effective implementation of Quality Management System in R & D such as Change Control System, Deviations, Incidence, Self inspection.