Hiring For IT CQA Team Member | Gurgaon Location

Hiring for IT CQA | Gurgaon Location

Key Accountabilities

• Execute and support Computerized System Validation (CSV) activities throughout the system lifecycle, including validation planning, risk assessment, protocol preparation, execution, review, reporting, change management, periodic review, and retirement activities.
• Review validation deliverables for computerized systems used in Manufacturing, Engineering, Quality Control, Quality Assurance, Warehouse, and other GxP functions to ensure systems remain in a validated state throughout their lifecycle.
• Design, develop, execute, and review manual and automated test scripts for GxP computerized systems, including Functional Testing, Integration Testing, System Testing, Regression Testing, User Acceptance Testing (UAT), and Performance Testing.
• Prepare and review validation documentation, including Validation Plans, User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Configuration Specifications, Risk Assessments, Requirement Traceability Matrices (RTM), IQ/OQ/PQ protocols, Validation Summary Reports (VSR), and validation evidence.
• Ensure validation and computerized systems comply with applicable regulatory requirements and industry guidelines, including GxP, FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, MHRA, PIC/S, WHO, and company procedures.
• Perform Quality IT surveillance and periodic reviews of GxP computerized systems to ensure continued compliance with data integrity principles and applicable Quality Management System requirements.
• Review electronic records, raw data, metadata, audit trails, user management, electronic signatures, security settings, backup and restore activities, access controls, and other IT controls from a Quality and Data Integrity perspective.
• Participate in implementation, qualification, upgrades, migration, configuration changes, and decommissioning of computerized systems while ensuring compliance with CSV and Data Integrity requirements.
• Collaborate with Business, IT, Engineering, Quality, and external vendors to understand system requirements and ensure validation activities adequately address intended use and regulatory expectations.
• Identify, document, investigate, and track validation observations, software defects, deviations, CAPAs, and change requests through closure while ensuring appropriate risk assessment and impact evaluation.
• Vendor assessments from a CSV and Data Integrity perspective, including review of supplier documentation and validation packages.
• Participate in Quality Risk Management (QRM) activities related to computerized systems and provide recommendations to mitigate quality, compliance, cybersecurity, and data integrity risks.
• Review system configurations, user roles and privileges, password management, audit trail configuration, time synchronization, backup, disaster recovery, and business continuity arrangements to ensure compliance with internal procedures and regulatory requirements.
• Prepare, review, and maintain validation metrics, periodic review reports, compliance dashboards, and validation status reports for management review.
• Support internal audits, self-inspections, customer audits, and regulatory inspections by providing CSV documentation, compliance evidence, and responses related to computerized systems.
• Develop, review, and maintain SOPs, templates, and corporate procedures related to Computerized System Validation, Data Integrity, Electronic Records, and Quality IT governance.
• Coordinate and deliver training on CSV, Data Integrity, Electronic Records & Electronic Signatures, and computerized system procedures, and evaluate training effectiveness.
• Continuously monitor evolving regulatory expectations and industry best practices to improve validation methodologies, testing approaches, and Quality IT compliance processes.

Any other additional responsibility could be assigned to the role holder from time to time as a standalone project or regular work. The same would be suitably represented in the Primary responsibilities and agreed between the incumbent, reporting officer and HR.

Skills & Capabilities

• Analytical and critical thinking capabilities
• Strong ethical values and commitment to compliance, integrity

Educational and Experience Requirements

Minimum Education Requirement

• MSc in Chemistry/MSC Computers

Experience

• 10 years of experience Quality of pharmaceutical or Information technology industry

You may share the CV at [email removed]