LABORATORY SYSTEMS CONSULTANT
Company: ProPharma
Location: India (Remote/Hybrid)
Department: Laboratory Informatics / Digital Laboratory Solutions
Job Type: Full-Time
JOB OVERVIEW
The Laboratory Systems Consultant supports the implementation, validation, and maintenance of laboratory informatics systems, including Electronic Laboratory Notebooks (ELN) and Laboratory Information Management Systems (LIMS), within regulated pharmaceutical and biopharmaceutical environments. The role focuses on computerized system validation (CSV), user acceptance testing (UAT), system configuration, requirements gathering, Agile testing, and ensuring GxP compliance.
KEY RESPONSIBILITIES
Laboratory Informatics Implementation
Support implementation, configuration, and enhancement of laboratory systems, including:
Electronic Laboratory Notebooks (ELN)
Laboratory Information Management Systems (LIMS)
Collaborate with stakeholders to ensure successful deployment and adoption.
Computerized System Validation (CSV)
Author validation documentation in compliance with GxP requirements.
Prepare:
User Acceptance Testing (UAT) protocols
Validation test scripts
Regression test documentation
Ensure validation deliverables meet regulatory standards.
Testing & Quality Assurance
Execute:
User Acceptance Testing (UAT)
Validation testing
Regression testing
Unit testing for sprint releases
Document test results, deviations, defects, and remediation activities.
Business & Laboratory Requirements
Gather, analyze, and document business and laboratory requirements.
Translate laboratory workflows into system requirements.
Maintain traceability between requirements, testing, and validation documentation.
Cross-Functional Collaboration
Work closely with:
Laboratory scientists
IT teams
Quality Assurance
System vendors
Support issue resolution and production readiness.
Defect & Release Management
Track system defects and coordinate resolutions.
Support Agile/Scrum sprint activities.
Ensure systems are ready for production deployment.
Documentation & Compliance
Maintain complete validation documentation.
Ensure compliance with:
GxP
Data Integrity principles
Regulatory requirements
Support inspection and audit readiness.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's degree in:
Biology
Chemistry
Biochemistry
Engineering
Computer Science
Other Scientific disciplines
EXPERIENCE REQUIREMENTS
Required
Minimum 5 years of Pharmaceutical or Biopharmaceutical industry experience.
Experience supporting laboratory informatics systems.
Experience with Computerized System Validation (CSV).
Experience writing and executing UAT and validation test scripts.
Preferred
Hands-on laboratory experience.
Experience in Agile or Scrum environments.
Experience working with regulated laboratory systems.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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