Manager - IT Quality

Designation: Manager

Office Location: Indore

Reporting to: Deputy General Manager

IT Quality

Role: Computerized System Validation IT QualityCompliance

Responsibilities

Computerized System Validation Lifecycle

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.

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 Computerized Systems

Provide compliance support to sites for routine monitoring of computerized systems.

Assist in preparation and implementation of periodic checklists for system compliance, access review, audit trail review, backup verification, and desktop policy controls.

Support site teams in maintaining computerized systems in a validated and compliant state.

Vendor Qualification and Periodic Review

Support vendor qualification, vendor audits, supplier periodic reviews, and evaluation of third-party service providers associated with GxP computerized systems.

Review supplier documentation, quality agreements, audit responses, CAPA commitments, and service-related compliance records.

Ensure vendor responsibilities are clearly defined and controlled through appropriate quality documentation.

Periodic Review and Continued Validation

Support periodic review of computerized systems to confirm continued compliance, validated state, and suitability for intended use.

Review system performance, changes, incidents, deviations, user access, audit trail controls, backup status, and open compliance actions.

Training and Capability Building

Prepare and deliver training on computerized system validation, IT compliance, data integrity, audit trail review, access control, backup/restore, and QMS processes.

Evaluate training effectiveness and support knowledge enhancement of site and cross-functional teams.

Compliance Monitoring and Reporting

Maintain trackers, dashboards, and compliance status reports for audit observations, gap assessments, CAPA, validation status, periodic reviews, and regulatory readiness.

Escalate critical compliance risks, overdue actions, and potential impact to patient safety, product quality, data integrity, or regulatory compliance.

Cross-Functional Coordination

Coordinate with QA, IT, QC, Manufacturing, Regulatory, Validation, system owners, process owners, and vendors for execution of computerized system compliance activities.

Ensure timely communication, documentation, and closure of assigned activities.

Documentation and Record Management

Ensure all assigned documents and records are accurate, complete, attributable, legible, contemporaneous, original, and maintained as per ALCOA+ principles.

Maintain appropriate evidence for validation, review, approval, training, audit, periodic review, and compliance activities.

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