Life Science Consultant, LIMS Project Manager (BBBH294) Hyderabad, India
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Life Science Consultant, LIMS Project Manager
Position: Life Science Consultant, LIMS Project Manager
Location: Remote (India and Malaysia)
Type: Full-Time
About the Role:
We are seeking an experienced LIMS Project Manager to lead the end-to-end implementation of a Laboratory Information Management System (LIMS). The successful candidate will play a critical role in ensuring a seamless digital transformation from paper-based to automated workflows, ensuring compliance with ISO 17025, cGMP, NPRA, and PIC/S standards.
This role requires strong project management expertise, regulatory knowledge, and experience with LIMS solutions tailored for regulated laboratory environments.
Key Responsibilities:
- Project Leadership
- Lead the end-to-end LIMS implementation, ensuring alignment with client’s operational, regulatory, and business needs.
- Define and manage project scope, budget, timelines, and key deliverables.
- Engage with R&D, Quality Control (QC), Production, IT, and regulatory teams to ensure smooth adoption of LIMS.
- Oversee the selection, validation, and deployment of the LIMS system, including data migration and system integration.
- Compliance & Validation
- Ensure LIMS meets ISO 17025, cGMP, NPRA, PIC/S, and FDA 21 CFR Part 11 requirements.
- Lead the GxP validation process, including URS (User Requirements Specification), IQ/OQ/PQ (Installation, Operational, and Performance Qualification), and CSV (Computer System Validation).
- Ensure audit readiness by implementing data integrity, security, and compliance measures.
- Workflow Automation & System Integration
- Oversee workflow digitization, including sample management, data tracking, instrument integration, and document control.
- Implement barcode-based tracking for sample lifecycle management.
- Work closely with IT to integrate LIMS with eQMS (Electronic Quality Management System), ELN (Electronic Lab Notebook), and other lab systems.
- Improve real-time reporting, analytics, and dashboarding capabilities for enhanced decision-making.
- Stakeholder & Vendor Management
- Collaborate with client's leadership team to align LIMS implementation with business growth and scalability goals.
- Act as the primary liaison with LIMS vendors, ensuring system customization to match client's unique workflows.
- Conduct training sessions and change management initiatives to drive system adoption across teams.
We offer great benefits
- Flat hierarchies and responsibility from the beginning
- People-oriented culture
- Diversity and inclusion-focused environment
- Global client projects in a multinational environment
- Flexible working hours and home office
- Involvement in global conferences
- Individual professional development, training, and coaching
We look forward to your application.
Your KVALITO Team