Manager- Quality Informatics

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.
  
  

Travel Estimate

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)

Various Service providers, Vendors, Customers, Regulatory Auditors.

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

Skills

Empower, LabX, LIMS, TrackWise, CSV, CSA, GAMP 5, Data Integrity (ALCOA+), Computerized System Validation (CSV), 21 CFR Part 11 & EU Annex 11 Compliance, Laboratory Systems, Regulatory Compliance.

Experience

08-12 Years in Quality IT Operations, Preferably in Pharma Manufacturing Quality (Injectable & OSD)

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).