16 Aug
|
MJ Biopharm
|
Pune
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 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
📌 Assistant Manager Information Technology (Pune)
🏢 MJ Biopharm
📍 Pune