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About the role
Position - Asst. Manager IT Experience - Minimum 12 to 15 year Location Pune Plant Drug Product Qualification – BSC (Comp), BCA, BCS, MCM, MCA or equivalent Department - IT Job Description. Function as IT compliance person on multiple assigned infrastructure projects for hardware replacements, upgrades, OS and Database patches and modifications to infrastructure needed to support quality systems and applications. Knowledge of different Pharma compliance like US FDA, EU, MHA etc. Take care of Lab Solution, UV, FTIR, EMS, BMS, TOC, Empower, PCS, FCS servers Managing & Monitoring. Create new database / projects / folders yearly and monthly, Users & assign authorization rights in all QC and Production instrument computers. Monthly and weekly backup as per SOP and GMP standards Develop strategy for the system qualification using a risk-based approach to determine testing, documentation and verification activities. Represent IT Documentation for internal and external regulatory audit. Develop new/ Fine-tune Centralized SOP (Standard Operating Procedures) and IT Policy Ensure processes are executed as defined in SOP. Create and execute system Qualification Plan, Protocols, Risk Assessment, CSV etc. Coordination with OEM vendor in case any troubleshooting in Quality system instrument/equipment etc. CCTV, Access Control, PSA, EPBX, Networking installation and troubleshooting. Good knowledge of Server, network and firewall monitoring and troubleshooting
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