IT -Assistant Manager || M.J.Biopharm Pvt. Ltd || Taloja - Navi Mumbai

Role & Responsibilities

• 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.
• Good Knowledge of ERP like SAP, Microsoft Dynamic, Oracle etc. is must.
• 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, PAS, EPBX, Networking installation and troubleshooting.
• Good knowledge of Server, networking and firewall monitoring and troubleshooting .

Interested applicant can send CV on janhavi.shedekar@mjbiopharm.com or contact on 9619744167.

Preferred candidate profile

Must have working experience of Pharmaceutical Industry

Perks and benefits

Free Pickup and Drop service and Canteen Facility.