Sarath Babu Chintha

·   Review of Qualification and Validation activities (CQV) and other QMS integrated functions.

·   Preparation of Standard operating procedures for Quality Assurance department.

·   Monitoring of the IQ and OQ activities and handling of the deviations if any.

·   Conducting Quality Risk Management exercise’s for facility layouts, utilities and equipment.

·   Review of validation life cycle of equipment and utilities.

·   Provide training for team members on Qualification and validation activities. 

·   Preparation of Validation Master Plan.

·   Review of Equipment / Utility / Process validation protocols.

·   Preparation and review of SOPs related to the validation activities.

·   Track the CQV (Commissioning, Qualification and Validation) schedule’s and escalate the impact of the validation activities.

·   Initiation, tracking and closure of change controls, Deviations, CAPAs and internal audit observations pertaining to qualifications/ validations.