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 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.
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.