• Preparation of BMR and BPR of the vaccines as per manufacturing and their review before release of the batch.• Preparation of SOPs & calibration and validation reports.• Major Equipments- D.H.S, Autoclave, M.C.D.P., Utilities validation (D.Q, I.Q, O.Q, P.Q).• Validation of HVAC system (P.Q of all critical parameters).• Review of Equipment Qualification document.• To evaluate the results of the validation activity.• To ensure that the manufacturing process is going as per the Master formula record.• Handling of deviation and change control.• Manufacturing compliance activity and handling of corrective and preventive action.• Area monitoring and cross checking of log books in production area.• Line clearance during product change over (Campaign Change).• Product Recall - Handling of market complaints as per SOP and maintaining its record.• Preparation and revision of Site Master File (SMF) and Validation Master Plan (VMP).• Conduct of self inspection and facing regulatory inspection.• Environmental monitoring (Microbial monitoring).