Sr. Executive

Principal Task And Responsibilities

 Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments Develop validation documentation for pharmaceutical equipment, facilities and computerized systems. Having experience in writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report). Experience in any other validations (cleaning, process, etc.), temperature mapping etc. At least 2 years work experience/exposure to CSV, US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5 Need to have good communication and technical writing skill PLC System Validation Project - Execution Documentation SCADA Validation Project - Execution, Documentation BMS Validation Project - Execution , Documentation LAB Software Validation Experience as Administrator for lab Instrument /Equipment Software available in QC. Managing Administrative activity of GxP Manufacturing Application. Manage monthly manual backup, Project Creation and periodic preventive maintenance of Lab equipment system. Manage Active user list , Audit trail , inventory of all instruments and equipment’s Maintain Document as per IT SOP’S & Performed Administrator related activity for GxP Systems. Ensure verification of Backup and restoration on periodic basis by centralized backup system.Next Responsible Person: QA HeadIn the absence of the jobholder, the designee assigned by the reporting manager would be responsible for carrying out the above responsibilities.