Manager- Quality Informatics

Designation : Manager

Function : QC

Functional Area : Quality Control

Job Role Summary : 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.

Job Profile :

• 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.

Job Requirements :

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

Work / Job Experience : 8-12 Years

Type of Experience : Quality IT Operations, Managing QC Instruments softwares, CSV

Academic Qualifications :

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

Job Post Link : https://tinyurl.com/mues4er3