The IT QC Subject Matter Expert (SME) will serve as the primary expert and point of contact for quality control -related computerized systems, such as CDS Empower, Moda EM, WinKQCL, Tiamo and SoftMax Pro. This role ensures that these systems are designed, maintained, and operated in compliance with GxP, data integrity principles, and internal quality standards. The SME will work with L3 support, enhancements, projects and lifecycle management. The IT QC SME partners closely with QC, IT, and business stakeholders to provide guidance on regulatory requirements, support system lifecycle activities, drive continuous improvement, and ensure that quality processes are fully and accurately supported by the systems.
Key Responsibilitie
s·Serve as system SME for QC IT systems, such as CDS Empower, Moda EM WinKQCL and SoftMax Pro providing expert guidance on functionality, compliance, and best practices
.·Provide L3 support, enhancements, projects and lifecycle management
.·Support quality system processes (e.g., document management, training, change control, deviations, CAPA, laboratory operations) through system configuration oversight, governance, and troubleshooting
.·Ensure GxP compliance and data integrity across all assigned systems, including review and approval of validation documents, change controls, periodic reviews, and audit trails
.·Partner with QC and IT teams to assess system changes, upgrades, and enhancements, ensuring that quality and compliance impacts are fully understood and appropriately managed
.Contributes to the evolution and implementation of the Lonza roadmap for applications, operations, and services in the portfolio
.·Develop, review, and maintain SOPs, work instructions, and procedures related to system use, data integrity, and system lifecycle management
.·Ensures compliance with the Lonza Validation framework and all relevant local, global, industry and regulatory policies and guidelines
.·Ensure adherence to GMP regulations and IT security policies of new and enhanced solutions
.·Provide training and guidance to end users and stakeholders to ensure proper and compliant use of the systems
.·Stays up to date with external best practices and the latest process and technology advancements in the field and uses this knowledge to develop and maintain role capability
.·Support audits and inspections, acting as system expert to provide evidence, documentation, and explanations of system controls and QC oversight
.·Drive continuous improvement initiatives, identifying opportunities to optimize quality processes, strengthen controls, and enhance system usability and compliance
.·Perform other duties as assigned
.Qualification
sEducation
:Preferred: Bachelor's degree in Computer Science, Life Sciences, or related field
.Experience
:4+ years hands-on experience with QC systems (such as CDS Empower, Moda EM, Tiamo, WinKQCL and SoftMax Pro
)Strong understanding of GxP principles, data integrity (ALCOA+), 21 CFR Part 11, Annex 11, and QC processes
.Familiarity with quality systems such as change control, deviations, CAPA, training management, and document control
.Knowledge of CSV concepts and system lifecycle management (GAMP 5) is a strong plus
.Skills
:Understanding of CDS Empower, Moda EM, Tiamo, WinKQCL and SoftMax Pro, workflows, and configuration
.Knowledge of GAMP 5, FDA 21 CFR Part 11, ALCOA and data integrity principles
.Excellent documentation and communication skills
.IQ and OQ Test Cases development and executio
nSoft Skill
sAbility to work under time pressure and manage multiple priorities effectively
.Strong problem-solving and analytical thinking
.Team-oriented with excellent collaboration and interpersonal skills
.Business fluent in Englis
h Role: QC Lead – IT Operations (IT QC SM
E)Location: Hyderab
ad Summ
aryThe IT QC Subject Matter Expert (SME) will serve as the primary expert and point of contact for quality‑related computerized systems, including Veeva DMS, Veeva QMS, Veeva RIM, Cornerstone, TrackWise, OpenText DMS, and QC laboratory systems such as CDS Empower, Moda EM, WinKQCL, Tiamo, and SoftMax Pro. This role ensures that these systems are designed, maintained, and operated in compliance with GxP, data integrity principles, and internal quality standards. The SME will provide L3 support, manage enhancements, oversee projects, and ensure lifecycle management. Partnering closely with QA, QC, IT, and business stakeholders, the SME will guide regulatory compliance, support audits, drive continuous improvement, and ensure quality processes are fully and accurately supported by IT syste
ms. Key Accountabili
tiesServe as system SME for QA and QC IT systems, providing expert guidance on functionality, compliance, and best practi
ces.Provide L3 support, manage enhancements, projects, and lifecycle activit
ies.Support quality system processes (document management, training, change control, deviations, CAPA, laboratory operations) through configuration oversight, governance, and troubleshoot
ing.Ensure GxP compliance and data integrity across all assigned systems, including validation documents, change controls, periodic reviews, and audit tra
ils.Partner with QA, QC, and IT teams to assess system changes, upgrades, and enhancements, ensuring compliance impacts are fully mana
ged.Develop, review, and maintain SOPs, work instructions, and procedures related to system use, data integrity, and lifecycle managem
ent.Ensure compliance with Lonza's validation framework and relevant global, local, and industry regulati
ons.Contribute to the evolution and implementation of Lonza's roadmap for applications, operations, and servi
ces.Provide training and guidance to end users and stakeholders to ensure compliant system
use.Support audits and inspections, acting as system expert to provide evidence, documentation, and explanations of system contr
ols.Drive continuous improvement initiatives to optimize quality processes, strengthen controls, and enhance usability and complia
nce.Perform other duties as assig
ned.Requirem
entsEducation & Experi
enceBachelor's degree in Computer Science, Life Sciences, or related field (preferr
ed).4+ years of hands‑on experience with QA/QC systems (Veeva DMS, Veeva QMS, Veeva RIM, Cornerstone, TrackWise, OpenText DMS, CDS Empower, Moda EM, WinKQCL, Tiamo, SoftMax P
ro).Strong understanding of GxP principles, data integrity (ALCOA+), FDA 21 CFR Part 11, Annex 11, and QA/QC proces
ses.Familiarity with quality systems such as change control, deviations, CAPA, training management, and document cont
rol.Knowledge of CSV concepts and system lifecycle management (GAMP 5) is a strong p
lus.Exposure to laboratory operations, QC workflows, and LIMS or integrated lab systems is desira
ble.Skills & Competen
ciesUnderstanding of QA/QC systems architecture, workflows, and configurat
ion.Knowledge of GAMP 5, FDA 21 CFR Part 11, ALCOA+ and data integrity princip
les.Excellent documentation and communication ski
lls.Experience in IQ/OQ test case development and execut
ion.Soft Sk
illsAbility to work under time pressure and manage multiple priorities effectiv
ely.Strong problem‑solving and analytical think
ing.Proactive in identifying and troubleshooting potential iss
ues.Team‑oriented with excellent collaboration and interpersonal ski
lls.Ability to contribute to business strategy and transformation roadm
aps.Business fluent in Engl
ish.About L
onzaAt Lonza, our people are our greatest strength. With more than 30 sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values—Collaboration, Accountability, Excellence, Passion, and Integrity—reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. Lonza is committed to creating an inclusive environment for all employ
