Glenmark Pharmaceuticals

Role: Computerized System Validation &amp; IT Quality Compliance
<ul>
<li>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.</li>
<li>Ensure validation deliverables are complete, traceable, risk-based, and aligned with applicable regulatory and internal quality requirements.</li>
</ul>
Responsibilities
<ul>
<li>Regulatory Compliance and Data Integrity</li>
<li>Ensure computerized systems comply with applicable expectations for electronic records, electronic signatures, audit trails, access controls, backup/restore, and data integrity.</li>
<li>Support implementation of controls aligned with GMP, 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable pharmacopeial expectations.</li>
<li>Quality Management System Support</li>
<li>Prepare, review, and support approval of SOPs, policies, work instructions, templates, and checklists related to computerized systems and IT quality compliance.</li>
<li>Review and provide quality assessment for change controls, incidents, deviations, investigations, CAPA, and other QMS records impacting computerized systems.</li>
<li>Internal Audits and Inspection Readiness</li>
<li>Participate in internal audits and compliance assessments for computerized systems at manufacturing sites and corporate functions.</li>
<li>Identify compliance gaps, document observations, support CAPA definition, and track remediation actions to closure.</li>
<li>Maintain inspection readiness for computerized system validation and IT compliance areas.</li>
<li>Gap Assessment and Risk Management</li>
<li>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.</li>
<li>Prepare and review documented risk assessments for gaps, legacy systems, and non-compliant computerized system controls.</li>
<li>Recommend interim controls and long-term remediation strategies based on quality risk management principles.</li>
<li>Site Support for GxP Computerized Systems</li>
<li>Provide compliance support to sites for routine monitoring of computerized systems.</li>
<li>Assist in preparation and implementation of periodic checklists for system compliance, access review, audit trail review, backup verification, and desktop policy controls.</li>
<li>Support site teams in maintaining computerized systems in a validated and compliant state.</li>
<li>Vendor Qualification and Periodic Review</li>
<li>Support vendor qualification, vendor audits, supplier periodic reviews, and evaluation of third-party service providers associated with GxP computerized systems.</li>
<li>Review supplier documentation, quality agreements, audit responses, CAPA commitments, and service-related compliance records.</li>
<li>Ensure vendor responsibilities are clearly defined and controlled through appropriate quality documentation.</li>
<li>Periodic Review and Continued Validation</li>
<li>Support periodic review of computerized systems to confirm continued compliance, validated state, and suitability for intended use.</li>
<li>Review system performance, changes, incidents, deviations, user access, audit trail controls, backup status, and open compliance actions.</li>
<li>Training and Capability Building</li>
<li>Prepare and deliver training on computerized system validation, IT compliance, data integrity, audit trail review, access control, backup/restore, and QMS processes.</li>
<li>Evaluate training effectiveness and support knowledge enhancement of site and cross-functional teams.</li>
<li>Compliance Monitoring and Reporting</li>
<li>Maintain trackers, dashboards, and compliance status reports for audit observations, gap assessments, CAPA, validation status, periodic reviews, and regulatory readiness.</li>
<li>Escalate critical compliance risks, overdue actions, and potential impact to patient safety, product quality, data integrity, or regulatory compliance.</li>
<li>Cross-Functional Coordination</li>
<li>Coordinate with QA, IT, QC, Manufacturing, Regulatory, Validation, system owners, process owners, and vendors for execution of computerized system compliance activities.</li>
<li>Ensure timely communication, documentation, and closure of assigned activities.</li>
<li>Documentation and Record Management</li>
<li>Ensure all assigned documents and records are accurate, complete, attributable, legible, contemporaneous, original, and maintained as per ALCOA+ principles.</li>
<li>Maintain appropriate evidence for validation, review, approval, training, audit, periodic review, and compliance activities.</li>
</ul>
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
<ul>
<li>Computerized System Validation (CSV)</li>
<li>IT Quality Compliance</li>
<li>Data Integrity Programs</li>
</ul>

Manager IT CQA

Manager IT CQA

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