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 current 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 current/ 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.
Positive knowledge of Server, network and firewall monitoring and troubleshooting

📌 Assistant Manager Information Technology Pune
🏢 MJ Biopharm
📍 Pune