 Handling of Change Management system Preparation of Validation Documents. Review of Vendor Questionnaires. Review of Qualification Documents. Review of MPCRs. Review of MCVRs. Monitoring of Validation batch activities. Handling of System related Deviations, Incidence Management and Change Controls. Conducting Internal Audit.

 Handling of documents, change control, OOS, OOT, Product failure investigation, deviation, vendor questionnaire & Market complaint. Conducting training as per schedule. Conducting the vendor audit. Preparation & review of Validation Documents (Process, Pulverizing, Drying, Blending, Analytical, Cleaning, Water System & Air System). Preparation & review of Qualification Verification documents & Review the same.  Preparation of Audit compliance report. Preparation of Annual Product Quality Review.  Scrutinize the HPLC system. Preparation of the Site Master file. Plant rounds, Line clearance and monitoring of cGMP operations in plant. Preparation, reviewing & revision of SOPs.  Preparation of documents which are required in internal as well as external audits.For RA in Tonira Pharma Ltd (RA related activities) Preparation of gap analysis for regulatory submitted product. Providing all necessary data / inputs for filing the DMF Preparation of dossier with help of dept. head. Preparation of comparison data of Inprocess & intermediate specification. Preparation of Batch comparison data for justification.

 Preparation & revision of SOPs.  Preparation of the Qualification documents.  Preparation of Validation protocols and reports. Plant rounds, Line clearance and monitory of cGMP operations in plant. Preparation of air validation document.  BMR reviewing and archiving. Handling of documents, change control, OOS, deviation control, vendor questionnaire.