Tech Qualitas

Gurgaon, Haryana

About Tech QualitasTech Qualitas is a quality-driven service provider focused on serving the pharmaceutical, biotech, medical device, and CRO companies in following areas/domains: Computer System Validation IT/QA Services GDPR, HIPAA Compliance Spreadsheet Validation Auditing Services (Third Party GMP Audits, Internal Audit Management Program, Vendor and Supplier Management Program, Response to Audit Observations) Compliant & Secure Software Development Life Cycle Sterilization Process Validation (Gamma Sterilization as per ISO 11137, EO Sterilization as per ISO 11135, Steam Sterilization as per ISO 17665/WHO PDA Technical Report Series etc.) Consultancy for Pharmaceutical Microbiology and Contamination Control (Facility Walkthrough and Assessment, Utilities Assessment, Clean Rooms/HVAC Validation and routine controls, Cleaning Validation, Sterility, Bioburden, Endotoxin, Disinfectant Validation, Media Fill Validations, Water Analysis as per USP chapters)Job TitleEngineer/Lead Engineer GxP Systems at GMP SitesYour Job ResponsibilitiesAs an Engineering Lead, you will be responsible for overall IT Administration of GxP Systems including User Account Management on daily basis Creation, Removal, Periodic Review Daily/Monthly/Yearly Backup, Restoration and Archival of all GxP Systems (Instruments, IPCs, HMIs, Servers and Application) Installation of application on clients Provide support as an Administrator to Application/System Vendors During Qualification of new Application/Instruments, provide support as an Executor to Service Engineer & QC team Applying Security group on Local Drive of Computer system for restricting access & deletion of data Documentation Maintenance such as Active Users List, Backup Logs, Labelling of backup tape media and maintaining the log of media with retention data etc. Prepare Monthly/Annual Preventive Maintenance Planner for Computers, Servers, UPS, etc. Administration of QC and Production Domain