Computer System Validation (CSV) Consultant

Location : Pan India / Hybrid (As per Project Requirement)

Experience : 6+ Years

Employment Type : Full-Time, Permanent

About the Role :

We are seeking an experienced Computer System Validation (CSV) Consultant to support validation initiatives for global pharmaceutical and life sciences organizations. The ideal candidate will have strong expertise in Computer System Validation (CSV), regulatory compliance, and validation methodologies, with hands-on experience validating enterprise applications such as SAP, LIMS, MES, and Quality Management Systems (QMS). As a CSV Consultant, you will lead validation activities throughout the system lifecycle, ensuring compliance with global regulatory requirements including FDA 21 CFR Part 11, GAMP 5, EU Annex 11, GxP, and ALCOA+ data integrity principles. You will collaborate with cross-functional teams on global implementation and rollout projects while ensuring validated systems meet quality and compliance standards.

Key Responsibilities :

1. Computer System Validation (CSV) :

- Lead end-to-end Computer System Validation (CSV) activities for regulated pharmaceutical and life sciences environments.

- Develop and execute validation strategies, plans, protocols, and reports in accordance with regulatory guidelines.

- Perform system validation across the software development lifecycle, from requirements through deployment and maintenance.

- Ensure validated systems comply with internal quality standards and regulatory expectations.

2. Validation Documentation :

- Prepare, review, and maintain validation documentation, including :

1. Validation Plans (VP)

2. User Requirements Specifications (URS)

3. Functional Specifications (FS)

4. Design Specifications (DS)

5. Installation Qualification (IQ)

6. Operational Qualification (OQ)

7. Performance Qualification (PQ)

8. Traceability Matrix (TM)

9. Validation Summary Reports (VSR)

10. Standard Operating Procedures (SOPs)

- Ensure documentation is complete, accurate, and audit-ready.

3. Regulatory Compliance :

- Ensure compliance with industry regulations and standards, including GxP, FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and ALCOA+ Data Integrity Principles.

- Support internal, customer, and regulatory audits by providing validation evidence and documentation.

- Stay updated with evolving regulatory requirements and industry best practices.

4. Enterprise Systems Validation :

- Validate enterprise applications such as SAP, Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), and Quality Management Systems (QMS) including TrackWise.

- Support system implementation, upgrades, enhancements, migrations, and change management activities.

- Perform impact assessments and validation activities for system changes.

5. Risk-Based Validation :

- Apply risk-based validation methodologies to optimize validation efforts while maintaining regulatory compliance.

- Conduct risk assessments to determine validation scope and testing requirements.

- Ensure validation activities align with business risks and regulatory expectations.

6. Project Delivery :

- Participate in global implementation and rollout projects for validated systems.

- Manage multiple validation projects simultaneously while meeting project timelines.

- Coordinate with business users, IT teams, quality assurance, and vendors throughout the validation lifecycle.

- Monitor project progress, identify risks, and implement mitigation plans.

7. Stakeholder Collaboration :

- Work closely with Quality Assurance, Regulatory Affairs, IT, Engineering, Manufacturing, and business stakeholders.

- Facilitate validation workshops and review sessions.

- Provide guidance on validation best practices and regulatory compliance.

- Mentor junior consultants and support knowledge-sharing initiatives.

Required Skills :

- Computer System Validation (CSV), GxP Compliance, FDA 21 CFR Part 11, GAMP 5, EU Annex 11, ALCOA+ Data Integrity, Risk-Based Validation, Validation Lifecycle Management, SAP Validation, LIMS, MES, QMS, TrackWise, IQ, OQ, PQ, URS, FS, DS, Validation Documentation, Change Control, CAPA, Audit Support, Stakeholder Management, Pharmaceutical Industry, Life Sciences, Project Management.

Preferred Qualifications :

- Bachelor's degree in Engineering, Computer Science, Information Technology, Pharmacy, Life Sciences, or a related field.

- 6+ years of experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry.

- Proven experience handling global implementation and rollout projects.

- Strong knowledge of GxP, FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and other regulatory standards.

- Hands-on experience validating enterprise systems such as SAP, LIMS, MES, and QMS (TrackWise preferred).

- Experience applying risk-based validation methodologies and ALCOA+ data integrity principles.

- Excellent documentation, analytical, problem-solving, and communication skills.

- Ability to manage multiple validation projects and lead cross-functional teams.

- Experience supporting regulatory inspections and compliance audits is an added advantage.