Job Description

Principal task and Responsibilities: xefx83xa8 Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments xefx83xa8 Develop validation documentation for pharmaceutical equipment, facilities and computerized systems. xefx83xa8 Having experience in writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report). xefx83xa8 Experience in any other validations (cleaning, process, etc.), temperature mapping etc. xefx83xa8 At least 2 years work experience/exposure to CSV, US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5 xefx83xa8 Need to have good communication and technical writing skill xefx83xa8 PLC System Validation Project - Execution Documentation SCADA Validation Project - Execution, Documentation BMS Validation Project - Execution , Documentation LAB Software Validation xefx83xa8 Experience as Administrator for lab Instrument /Equipment Software available in QC. xefx83xa8 Managing Administrative activity of GxP Manufacturing Application. xefx83xa8 Manage monthly manual backup, Project Creation and periodic preventive maintenance of Lab equipment system. xefx83xa8 Manage Active user list , Audit trail , inventory of all instruments and equipments xefx83xa8 Maintain Document as per IT SOPS & Performed Administrator related activity for GxP Systems. xefx83xa8 Ensure verification of Backup and restoration on periodic basis by centralized backup system. Next Responsible Person: QA Head In the absence of the jobholder, the designee assigned by the reporting manager would be responsible for carrying out the above responsibilities.

Cadila Pharmaceuticals