Assistant Manager - IT Quality Assurance & Computer System Validation

To manage and execute IT Quality Management System (QMS), Computer System Validation (CSV), GxP compliance, data integrity, and computerized system lifecycle activities in accordance with applicable regulatory requirements and internal procedures.

Role & responsibilities :

1. IT Quality Management System (QMS)

• Initiation, monitoring, tracking, and closure of IT-related Change Controls, CAPA, Deviations, Risk Assessments, and QRAF.
• Ensure compliance with applicable GMP, GxP, and internal quality procedures.
• Coordinate with Quality Assurance and cross-functional departments for effective implementation of QMS activities.

2. Computer System Validation (CSV) Support

• Review and provide technical inputs on CSV qualification documents, including URS, Risk Assessments, IQ, OQ, PQ, and validation protocols, as applicable.
• Support the preparation and review of qualification protocols by evaluating IT infrastructure, network security, system security, and logical access controls.
• Identify IT-related compliance gaps and recommend appropriate improvements and change actions.
• Review and support the implementation of IT-related change control actions arising from qualification, validation, and audit activities.
• Coordinate with CSV, QA, and IT teams to ensure IT-related qualification and compliance requirements are adequately addressed.

3. Regulatory Compliance & Data Integrity

• Ensure computerized systems comply with applicable requirements, including GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, cGMP, and Data Integrity principles.
• Support Electronic Records and Electronic Signatures (ERES) assessments.
• Evaluate system controls, audit trails, user access, and data integrity requirements.

4. IT Application & System Administration Support

• Coordinate with IT team technical team, validation team and application owners for administration and compliance of GxP computerized systems.
• Support User Access Management, periodic access reviews, and role-based access controls.
• Coordinate backup and restoration verification for GxP applications.
• Support IT infrastructure and application documentation for QC, Production, Engineering, and other departments.

5. Change Control, CAPA & Risk Management

• Manage IT-related Change Controls, CAPA, Deviations, and Risk Assessments.
• Evaluate the impact of changes to validated computerized systems.
• Ensure appropriate validation activities are identified and completed before system release.
• Track corrective and preventive actions through closure.

6. Audit Trail Review & Periodic Review

• Coordinate and perform periodic audit trail reviews for applicable GxP computerized IT systems.
• Support periodic assessment of validated systems and associated controls.
• Identify potential compliance gaps and coordinate corrective actions.
• Maintain appropriate documentation and records of review activities.

7. SOP & Documentation Management

• Prepare, review, revise, and implement IT SOPs, work instructions, and validation procedures.
• Maintain controlled documentation related to IT QMS, CSV, and computerized system lifecycle management.
• Ensure documentation is maintained in accordance with approved procedures.

8. Training & Awareness

• Conduct training for IT personnel, application owners, and relevant users on CSV procedures, IT SOPs, GxP compliance, Data Integrity, and User Access Management.
• Maintain training records and support training effectiveness where applicable.

9. Audit & Inspection Support

• Support internal audits, self-inspections, regulatory inspections, and customer audits.
• Prepare compliance documentation and responses to audit observations.
• Coordinate with relevant departments to track and close compliance actions.

10. Cross-Functional Coordination

• Coordinate with IT, QA, QC, Production, Engineering, and other stakeholders for effective execution of IT QMS and CSV activities.
• Provide technical and compliance support during system implementation, qualification, and change management.
• Ensure timely completion of assigned validation and quality activities.

Preferred Qualifications & Experience

• Qualification in Computer Science, Information Technology, Engineering, Pharmacy, or a related discipline.
• Relevant experience in pharmaceutical IT Quality Assurance, CSV, QMS, or GxP computerized system compliance.
• Practical knowledge of GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, cGMP, and Data Integrity requirements.
• Experience in validation documentation, risk assessment, user access management, audit trail review, DR ,backup and restoration, and periodic review.
• Ability to coordinate effectively with IT, QA, QC, Production, Engineering, and other cross-functional teams.

Key Competencies

• IT Quality Assurance and CSV lifecycle management
• Regulatory and GxP compliance
• QMS handling and documentation control
• Risk assessment and change management
• Audit and inspection readiness
• Stakeholder coordination and communication
• Training and knowledge transfer

Desired Skills & Experience:

Experience in IT QMS, GxP IT Compliance, and IT Systems Process Review within the pharmaceutical industry. Responsibilities include managing Change Controls, Deviations, CAPA, QRAF, Risk Assessments, IT asset management, user access management, system security, software decommissioning, SOP management, audit compliance reports, and periodic IT systems reviews.

The role also involves supporting IT technical team, CSV teams on IT-related compliance requirements, coordinating with cross-functional departments, conducting IT SOP and GMP training, and ensuring IT operations comply with approved SOPs and regulatory requirements.