Experience in Process validation Protocol,Report,QMS,Vendor Qualification.Preparation of Validation Master plan, Site Master File. 2. Preparation and Review of Standard operating Procedures 3. To co-ordinate for Qualification / Validation of the Equipment, Systems and Process. 4. Preparation and Review of Qualification documents for Equipment, Instruments and Systems (URS, SAT, FAT, DQ, IQ, OQ & PQ). 5. Preparation of Process validation Protocols and summary reports based on the Analytical results and Batch documents data. 6. To participate in the validation of quality processes by establishing product specifications and quality attributes. 7. Preparation of Annual Product Quality Review. 8. Vendor qualification and management activity for Raw Materials and Packing Materials. 9. Preparation, Review and revision of Lists and Schedule 10. Review of BMR, Process Validation Report, Hold time Report 11. To ensure compliance with appropriate SOP’s, policies and guidelines. 12. During GMP – QA round ensure that, all the Equipment / Instruments in plant and QC are Calibrated, check Preventive Maintenance status and online entries for Logbooks. 13. Any other responsibility assigned by reporting manager or management
