Position Overview

We are seeking an experienced Functional Expert in the Pharmaceutical domain with deep expertise in Laboratory Information Management System (LIMS) and Quality Management System (QMS). The ideal candidate will serve as a technical and functional bridge between business stakeholders, compliance teams, and development teams.

Key Responsibilities

- Design, implement, and maintain LIMS solutions across laboratory operations including sample tracking, testing workflows, and result reporting
- Develop and enforce QMS processes, documentation standards, and compliance protocols to meet FDA 21 CFR Part 11 and EMA Annex 11 requirements
- Gather functional requirements from laboratory and quality teams; translate business needs into technical specifications
- Lead configuration and customization of LIMS modules (sample management, analytics, ELN integration)
- Conduct regulatory impact assessments and ensure systems comply with pharma industry standards
- Provide training and documentation to end-users on LIMS and QMS workflows
- Collaborate with IT and external vendors for system maintenance, upgrades, and troubleshooting

Required Technical Knowledge

- LIMS (Laboratory Information Management System) – Strong hands-on experience with LIMS configuration, sample workflow management, and reporting
- QMS (Quality Management System)



– Design and maintenance of quality procedures, change management, document control, and audit trails
- DMS (Document Management System) – Implementation and governance of electronic documentation systems
- TMS (Test Management System) – Testing protocols, test case management, and batch record documentation
- Regulatory Frameworks – FDA 21 CFR Part 11, EMA Annex 11, ICH guidelines, and GxP standards (GMP, GLP, GCP)

Required Skills & Experience

- 7+ years of experience in pharmaceutical or life sciences sector
- 5+ years of hands-on experience with LIMS implementation and management
- Solid understanding of pharmaceutical development lifecycle (R&D;, manufacturing, quality)
- Experience with LIMS vendors (Waters, Labware, LabLynxx, etc.) or custom LIMS solutions
- Proficiency in SQL, data modeling, and basic database administration
- Excellent documentation and communication skills
- Project management and cross-functional collaboration abilities

Desirable Qualifications

- Bachelor's degree in Chemistry, Life Sciences, or related field
- Certification in quality management or compliance (ASQ, ISPE, or equivalent)
- Experience with ELN (Electronic Lab Notebook) systems
- Knowledge of HL7 and LOINC standards for lab data integration

📌 FUNCTIONAL EXPERT – PHARMA DOMAIN (LIMS & QMS) (Hyderabad)
🏢 CittaAI
📍 Hyderabad