It Manager / IT Admin Manager (Information Technology )

21

Key responsibilities:

• Manage and maintain IT infrastructure: servers, networks, data centres, backup systems, and cloud services and ensure high availability of systems supporting manufacturing, QC, warehouse.
• Administer SAP, LIMS, Ample logic (QMS) DMS, and other validated systems.
• Coordinate with automation/engineering teams for integration of SCADA, PLC, BMS, EMS with IT networks (GMP segregated networks).
• Ensure all GMP-related IT systems comply with

  21

  CFR

  Part

  11,

  Annex

  11,

  Data

  Integrity

  ALCOA+

  , and GAMP 5 V-model validation.
• Lead CSV activities: URS, FS, DS, IQ, OQ, PQ, risk assessments, and periodic review.
• Implement and maintain audit trails, user access controls, Data backup/restore, and disaster recovery procedures and Support regulatory audits (WHO /CDSCO) and respond to IT-related queries or observations.
• Establish IT SOPs, policies, and governance framework for GMP and non-GMP areas and Manage IT service desk.
• Provide support for end-users in production, QC, QA, Purchase, Logistics, HR, and finance and implementation of new IT systems (SAP, LIMS, eQMS).
• Work with QA for system validation, change control, and deviation handling, with Production/Engineering for network connectivity of equipment and Support QC for analytical instrument connectivity

Required Qualifications:

• Bachelors/Master’s degree in IT, Computer Science, or related fields with 8–10 years of IT experience, with minimum 5 years in pharmaceutical/biotech/GMP regulated environments.
• Strong knowledge of:
• 21 CFR Part 11, Annex 11
• Data Integrity ALCOA+
• GAMP 5 guidelines/CSV (Computer System Validation)
• Network and cybersecurity

Key Skills

• Strong leadership & people management.
• Project management skills.
• Understanding of pharma manufacturing process flows.
• Excellent troubleshooting and analytical skills.
• Good communication and coordination ability with cross-functional teams.