ITSoli - Validation Lead - NuGenesis SDMS (5-15 yrs)

Designation: Validation Lead - NuGenesis SDMS

Qualification: Bachelor's / master's degree in computer science, Life Sciences, Pharmaceutical Sciences, or a related field. Certification in Computer System Validation (CSV) or GAMP would be an advantage.

Reports to: IT Delivery Lead / Validation Manager

Experience: Candidates with 6+ years in Computer System Validation (CSV) within the Life Sciences industry, with at least 3+ years of hands-on experience in validating NuGenesis Scientific Data Management System (SDMS).

Office Location: Indiranagar (Bangalore, Karnataka) - Remote Work Mode (WFH)

Work Timing: 7:00 PM - 4:00 AM (IST) / 8:30 PM - 5:30 AM (IST)

Job Role: The Validation Lead will be responsible for planning, executing, and managing validation activities for NuGenesis SDMS, ensuring compliance with regulatory requirements such as FDA 21 CFR Part 11, GAMP 5, and other applicable industry standards. The role involves working closely with cross-functional teams, including IT, Quality, and Business teams, to ensure system integrity, compliance, and operational efficiency.

Key Responsibilities:

1. Develop and execute validation strategies, protocols (IQ, OQ, PQ), and reports for NuGenesis SDMS in alignment with regulatory and company standards.

2. Ensure adherence to GxP, FDA 21 CFR Part 11, EU Annex 11, and other regulatory compliance requirements.

3. Lead validation efforts, including risk assessments, system configuration reviews, and test execution.

4. Collaborate with IT, Business, and Quality teams to define validation requirements and ensure end-to-end compliance.

5. Maintain validation documentation, including Validation Master Plans (VMP), Test Scripts, Change Control records, and Traceability Matrices.

6. Support audits and inspections by regulatory agencies and internal QA teams, providing necessary validation documentation and responses.

7. Oversee validation lifecycle management, including periodic review, revalidation, and change control impact assessments.

8. Train and mentor team members on validation processes and compliance best practices.

9. Troubleshoot validation issues and drive resolution through corrective and preventive actions (CAPA).

10. Stay updated with evolving regulatory guidelines and industry best practices for system validation.

Required Skills:

1. Strong expertise in Computer System Validation (CSV) within the Life Sciences industry.

2. Hands-on experience with NuGenesis SDMS validation, including installation, configuration, and compliance testing.

3. In-depth knowledge of FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and other relevant regulations.

4. Experience with validation documentation, including IQ, OQ, PQ, URS, FRS, and Traceability Matrices.

5. Proficiency in risk assessment methodologies for system validation.

6. Strong problem-solving skills and ability to manage validation-related deviations effectively.

7. Familiarity with change management and impact analysis in validated environments.

8. Excellent communication and documentation skills.

9. Experience supporting regulatory audits and responding to compliance queries.

Desired Skills:

1. Experience in other scientific data management or LIMS systems.

2. Knowledge of cloud-based validation and SaaS-based compliance requirements.

3. Understanding of automation tools for validation documentation.

4. Experience working in an Agile or hybrid project management environment.

Personal Attributes:

1. Detail-oriented with a strong focus on compliance and quality.

2. Ability to work independently and lead cross-functional teams.

3. Strong analytical and decision-making skills.

4. Proactive approach in problem-solving and issue resolution.

5. Adaptability to fast-paced and evolving regulatory environments.

6. Effective interpersonal skills for collaboration with stakeholders.