Role: Computerized System Validation & IT Quality Compliance

Support and execute validation activities for GxP computerized systems across the system lifecycle, including planning, risk assessment, testing, implementation, periodic review, change management, and retirement.
Ensure validation deliverables are complete, traceable, risk-based, and aligned with applicable regulatory and internal quality requirements.

Responsibilities

Regulatory Compliance and Data Integrity
Ensure computerized systems comply with applicable expectations for electronic records, electronic signatures, audit trails, access controls, backup/restore, and data integrity.
Support implementation of controls aligned with GMP, 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable pharmacopeial expectations.
Quality Management System Support
Prepare, review, and support approval of SOPs, policies, work instructions, templates, and checklists related to computerized systems and IT quality compliance.
Review and provide quality assessment for change controls, incidents, deviations, investigations, CAPA,



and other QMS records impacting computerized systems.
Internal Audits and Inspection Readiness
Participate in internal audits and compliance assessments for computerized systems at manufacturing sites and corporate functions.
Identify compliance gaps, document observations, support CAPA definition, and track remediation actions to closure.
Maintain inspection readiness for computerized system validation and IT compliance areas.
Gap Assessment and Risk Management
Perform gap assessments for system controls such as user access management, audit trail review, backup and restore, desktop policy compliance, data retention, and system administration.
Prepare and review documented risk assessments for gaps, legacy systems, and non-compliant computerized system controls.
Recommend interim controls and long-term remediation strategies based on quality risk management principles.
Site Support for GxP Computer

📌 Manager IT CQA (Indore)
🏢 Glenmark Pharmaceuticals
📍 Indore