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 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.

Qualifications: B.Pharm / M.Pharm / B.E. / B.Tech (IT, Computer Science, Electronics, Instrumentation, Chemical, Biotechnology) or M.Sc. in a relevant discipline. Experience: 10-15 years in relevant experience

- Computerized System Validation (CSV)
- IT Quality Compliance
- Data Integrity Programs

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