Accountable for implementing and driving integrated quality management system.
Responsible for driving and motivating quality assurance and quality control departments to get in line with regulatory guidelines.
Responsible for performing product quality reviews and plant quality reviews.
Responsible for Monitoring & coordinating of stability studies with respect of ICH guidelines. Proven skills in handling of Product stability & Quality Issues, Critical changes observed during the studies at different intervals.
Responsible to ensure all deviations, OOS and Incidentetc., investigated with proper Risk assessment and CAPA.
Responsible for Manpower planning and maintaining Lab employees professional / regulatory training.
Management of site master file, quality manual, VMP etc. Performing site internal audits and coordinating to improve upon shortcomings as per cGMP requirements.
Responsible for companys product quality and reliability to meet or exceed customer expectations.