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.

📌 Manager It Cqa (Vasco da Gama)
🏢 Glenmark Pharmaceuticals
📍 Vasco da Gama