QMS Expert - Quality Assurance (OSD)

Role & responsibilities

• Responsible for review/approval of Investigation reports of market/ customer complaints / deviations /incidents and co-ordination to other departments for investigations process.
• Handling & investigations of out of specifications results and conclusions on disposition of batch.
• Evaluation of investigation and decision on returned goods / recalled products
• Overall responsibility for effective implementation of Quality Management system and compliance with GMP/GLP requirements.
• Review/ Approval of Validation Protocols and Reports of process validation, drying validations, cleaning validation, method validation, and system etc.
• Review of standard operating procedures and formats / annexure.
• Evaluation / Approval / Closing of change control, Deviation, corrective action & preventive action etc.
• To conduct the self-inspection and / or quality audit, unit operations that regularly appraises the effectiveness an applicability of the quality assurance system.
• Responsible for review of the annual product quality review of all the products.
• Responsible for Review monitoring for execution of quality risk management.
• Responsible for imparting of GMP trainings to all employee as per schedules.