Assistant Manager Information Technology

MJ Biopharm; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

MJ Biopharm in Pune seeks an experienced Assistant Manager IT to lead IT compliance across infrastructure projects and lab systems. You will manage GMP-aligned backups, QA/QC IT processes and instrument computer access for QC/Production teams. Strong regulatory awareness and vendor coordination are essential.

The role requires 12–15 years in IT within pharma, with a relevant degree. The position is on-site in Pune and reports to IT Department.

Qualifications

• Relevant IT qualifications with regulatory awareness.
• Experience in pharma IT and compliance processes.
• Ability to manage SOPs, audits and documentation.

Responsibilities

• Function as IT compliance lead on infrastructure projects.
• Handle lab solutions and instrument IT systems (Empower/PCS/FCS).
• Create databases and manage user access for QC/Production systems.
• Perform regular backups per SOP and GMP standards.
• Develop qualification strategies and CSV protocols.
• Represent IT in internal/external regulatory audits.
• Coordinate with vendors for troubleshooting IT equipment.
• Manage CCTV, access control, networking and security.

Skills

IT compliance

Infrastructure projects

Audits & regulatory

Backup management

Lab systems

Networking

Server administration

CSV awareness

Education

BSC (Comp)

BCA

BCS

MCM

MCA

Tools

Empower

TOC

PCS

FCS

BMS

UV

FTIR

EMS

Job description

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