Lead Consultant(Product/Domain) (India)

Lead Consultant(Product/Domain) (India)

05 Aug
|
HCLTech
|
India

05 Aug

HCLTech

India

Chennai, Tamil Nadu
Job Summary

LIMS & Environmental Monitoring (EM) Tester to support testing and validation of LIMS and Environmental Monitoring applications in a regulated pharmaceutical environment. The role requires expertise in laboratory workflows, environmental monitoring processes and GxP-compliant system validation.

Key Responsibilities

Perform Functional, Integration, Regression, and UAT testing for LIMS and EM applications.
Validate laboratory workflows including sample management, inventory, specifications, and results management.
Test Environmental Monitoring processes such as viable/non-viable monitoring, surface monitoring, personnel monitoring, and environmental reporting.
Execute and support CSV activities, including IQ/OQ/PQ and validation documentation.
Verify audit trails, electronic signatures, security roles, and data integrity controls.
Test integrations between LIMS, EM systems, laboratory instruments, SAP, ELN, and other enterprise applications.
Log, track, and support resolution of defects.
Ensure compliance with GxP, GMP, FDA 21 CFR Part 11, and ALCOA+ data integrity requirements.

I am creating a new SR for this requirement.

Key Responsibilities

LIMS & Environmental Monitoring (EM) Tester to support testing and validation of LIMS and Environmental Monitoring applications in a regulated pharmaceutical workplace. The role requires expertise in laboratory workflows, environmental monitoring processes and GxP-compliant system validation.

Key Responsibilities

Perform Functional, Integration, Regression, and UAT testing for LIMS and EM applications.
Validate laboratory workflows including sample management, inventory, specifications, and results management.
Test Environmental Monitoring processes such as viable/non-viable monitoring, surface monitoring, personnel monitoring, and environmental reporting.




Execute and support CSV activities, including IQ/OQ/PQ and validation documentation.
Verify audit trails, electronic signatures, security roles, and data integrity controls.
Test integrations between LIMS, EM systems, laboratory instruments, SAP, ELN, and other enterprise applications.
Log, track, and support resolution of defects.
Ensure compliance with GxP, GMP, FDA 21 CFR Part 11, and ALCOA+ data integrity requirements.

I am creating a recent SR for this requirement.

Skill Requirements

LIMS & Environmental Monitoring (EM) Tester to support testing and validation of LIMS and Environmental Monitoring applications in a regulated pharmaceutical environment. The role requires expertise in laboratory workflows, environmental monitoring processes and GxP-compliant system validation.

Key Responsibilities

Perform Functional, Integration, Regression, and UAT testing for LIMS and EM applications.
Validate laboratory workflows including sample management, inventory, specifications, and results management.
Test Environmental Monitoring processes such as viable/non-viable monitoring, surface monitoring, personnel monitoring, and environmental reporting.
Execute and support CSV activities, including IQ/OQ/PQ and validation documentation.
Verify audit trails, electronic signatures, security roles, and data integrity controls.
Test integrations between LIMS, EM systems, laboratory instruments, SAP, ELN, and other enterprise applications.
Log, track, and support resolution of defects.
Ensure compliance with GxP, GMP, FDA 21 CFR Part 11, and ALCOA+ data integrity requirements.

I am creating a new SR for this requirement.

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📌 Lead Consultant(Product/Domain) (India)
🏢 HCLTech
📍 India

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