Manager- Quality Informatics

Sun Pharmaceutical Industries, Inc.; Pithampur; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd is seeking a qualified professional to manage QC laboratory informatics systems and lead CSV activities across pharmaceutical manufacturing operations.

You will ensure data integrity, audit readiness, and end‑to‑end support for laboratory applications, instruments, and GxP‑compliant systems, collaborating with cross‑functional teams and external auditors.

Qualifications

• Bachelor's degree in a relevant discipline is required.
• Experience with CSV, validation documents, and regulatory compliance is essential.
• Knowledge of ALCOA+, GAMP 5 and 21 CFR Part 11 is preferred.

Responsibilities

• Administer and support laboratory informatics applications such as Empower, LabX, LIMS, CDS, and other GxP‑regulated laboratory systems.
• Serve as Site Administrator for quality laboratory applications and support multi‑site deployments where applicable.
• Lead CSV activities, including URS, Risk Assessments, Validation Plans, Configuration Specs, Test Scripts, Traceability Matrices, and Validation Reports.
• Execute IQ, OQ, PQ, system upgrades, and periodic validation reviews.
• Manage operating systems, servers, workstations, and instrument‑connected computers for laboratory operations.
• Ensure Data Integrity per ALCOA+ and compliance with GxP, 21 CFR Part 11, and Annex 11.

Skills

Laboratory informatics

GxP compliance

Data integrity

Education

Bachelor's degree in Computer Science, Information Technology, Electronics, Instrumentation, Automation Engineering, or related discipline

Tools

Empower

LabX

LIMS

CDS

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Summary

At Sun Pharma, we commit to helping you "Create your own sunshine" by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys.

Job Summary:

The Job holder will be responsible to managing QC laboratory systems, computer system validation, data integrity, and regulatory compliance across pharmaceutical manufacturing operations. Leads laboratory digitalization initiatives, ensures audit readiness, and provides end-to-end support for laboratory applications, instruments, and GxP-compliant computerized systems.

Demonstrates strong written and verbal communication skills to effectively collaborate with cross-functional teams, vendors, auditors, and regulatory stakeholders.

Areas Of Responsibility:

• Administer and support laboratory informatics applications such as Empower, LabX, LIMS, CDS, and other GxP-regulated laboratory systems.
• Serve as Site Administrator for quality laboratory applications and provide support for multi-site deployments where applicable.
• Lead and support Computer System Validation (CSV) activities, including preparation, review, and execution of validation documents such as URS, Risk Assessments, Validation Plans, Configuration Specifications, Test Scripts, Traceability Matrices, and Validation Reports.
• Execute and oversee IQ, OQ, PQ, system upgrades, and periodic validation reviews.
• Manage operating systems, servers, workstations, and instrument-connected computers supporting laboratory operations.
• Ensure compliance with Data Integrity principles (ALCOA+), GAMP 5, 21 CFR Part 11, Annex 11, and company quality standards.
• Administer user access management, role reviews, audit trail reviews, backup and restoration activities for laboratory systems and instruments.
• Support qualification, integration, and lifecycle management of laboratory instruments, balances, and computerized equipment.
• Investigate system-related deviations, incidents, and data integrity issues; perform root cause analysis and drive CAPA implementation through TrackWise or equivalent Quality Management Systems.
• Manage change controls, deviations, action items, and system releases in accordance with Quality and IT procedures.
• Coordinate with IT Infrastructure, Network, System security, Application Support teams, OEMs and business stakeholders to ensure uninterrupted laboratory operations.
• Develop, review, and maintain SOPs, validation records, forms, checklists, and controlled documentation.
• Support regulatory inspections, customer audits, and internal audits by ensuring systems remain compliant and inspection-ready.
• Support and drive continuous improvement, automation, and digital transformation initiatives within Quality and QC laboratory functions.
• Strong written and verbal communication skills to effectively engage stakeholders and collaborate across cross-functional teams.

Need Based

Job Scope

Internal Interactions (within the organization)

Plant Management, Business Users, Corporate IT Teams, Quality and CSV Teams

External Interactions (outside the organization)

Geographical Scope

Directly Manage site IT operation and at the same time provide onsite / offsite support to another site whenever needed.

Job Requirements

Educational Qualification

Bachelor's degree in Computer Science, Information Technology, Electronics, Instrumentation, Automation Engineering, or related discipline