Manager IT CQA

Glenmark Pharmaceuticals; Goa; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Glenmark Pharmaceuticals in Goa seeks a seasoned expert in Computerized System Validation and IT Quality Compliance to lead validation across the system lifecycle. The role emphasizes regulatory alignment for GxP systems, data integrity, and IT controls with strong cross-functional interaction.

You will collaborate with QA, IT, QC, Manufacturing, Regulatory, validation teams, and vendors to ensure inspection readiness and ongoing compliance with 21 CFR 11, EU Annex 11, and ALCOA+ principles.

Qualifications

• Bachelor's or higher in pharmacy, engineering or science.
• 10–15 years of relevant experience in validation and IT compliance.
• Experience with GMP, 21 CFR 11, EU Annex 11 guidance.

Responsibilities

• Support and execute validation activities for GxP computerized systems across the lifecycle.
• Ensure validation deliverables are complete, traceable, and risk-based.
• Support internal audits and inspection readiness for computerized systems.
• Prepare and review SOPs, policies, and templates related to IT quality compliance.
• Review change controls, incidents, deviations, CAPA, and other QMS records.
• Coordinate with QA, IT, QC, Manufacturing, Regulatory, Validation, system owners, and vendors.
• Maintain documentation per ALCOA+ principles and ensure evidence is kept.

Skills

Regulatory Compliance

Quality Assurance

Documentation

Risk Assessment

Cross-functional Collaboration

Education

B.Pharm / M.Pharm / B.E. / B.Tech (IT, CS, ECE, Instrumentation, Chemical, Biotechnology) or M.Sc.

Job description

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, and 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 inrelevant experience