07 Aug
|
Zensar
|
Aurangabad
Key Responsibilities
- Implement, configure, and maintain LIMS applications to support laboratory and business processes.
- Gather and analyze user requirements and translate them into system configurations and enhancements.
- Provide day-to-day support, troubleshooting, incident resolution, and system administration activities.
- Configure laboratory workflows, sample management processes, test methods, and reporting requirements.
- Perform system testing, UAT support, and deployment activities for enhancements and upgrades.
- Collaborate with QA, laboratory, and IT teams to ensure system reliability and compliance.
- Prepare, review, and maintain validation documentation including URS, FRS, IQ, OQ, PQ, RTM, and other validation deliverables.
- Support change control, deviation management, CAPA, and periodic review activities.
- Ensure compliance with applicable regulatory standards such as GxP, FDA 21 CFR Part 11, GAMP 5, and ALCOA+ principles.
- Participate in audits, inspections, and compliance assessments.
- Create and maintain SOPs, work instructions, and system documentation.
- Provide user training and knowledge transfer to laboratory and business teams.
Technical Skills
- Hands-on experience with LIMS platforms such as LabWare, LabVantage, STARLIMS, Thermo SampleManager, or equivalent.
- Experience in implementing, configuring, supporting, and maintaining LIMS solutions. [Details of...MS Analyst | Outlook]
- Robust understanding of laboratory workflows and sample lifecycle management.
- Knowledge of SQL, databases, and system integrations.
- Experience with incident management, change management, and release processes.
- Understanding of software development and validation lifecycles.
Domain Knowledge
- Pharmaceutical, Healthcare, Life Sciences, Biotechnology, or Laboratory domain experience. [Details of...MS Analyst | Outlook]
- Good understanding of GxP regulations and computerized system validation practices.
- Familiarity with regulatory expectations including FDA 21 CFR Part 11 and GAMP 5.
Qualifications
- Bachelor's degree in Computer Science, Information Technology, Biotechnology, Life Sciences, Pharmacy, or a related discipline.
- 3-5 years of relevant LIMS experience in a regulated environment.
📌 LIMS Analyst (Aurangabad)
🏢 Zensar
📍 Aurangabad