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Lab Validation Analyst

Cognizant

8 - 10 years

Kolkata

Posted: 3/30/2025

Job Description



Job Summary

We are seeking a skilled Analyst with 3 to 8 years of experience in Validation and Testing in Labware LIMS Labvantage LIMS GLIMS CDS and any Lab Systems.


Responsibilities

  • Experience/ exposure to Computerized System Validation (CSV) US FDA 21 CFR Part 11 EU Annex 11 and GAMP 5.
  • Experience of CSV Validation in any one of the Lab systems (LIMS CDS SDMS etc) is must.
  • Should worked in pharmaceutical domain and its related knowledge is must
  • Good communication and technical writing skills are a must
  • Developing validation documentation for pharmaceutical equipment facilities and computerized systems used in GLP GMP and GCP environments.
  • Project Deliverables will encompass validation plans specifications test protocols and standard operation procedures and systems may include Process Automation Laboratory Automation Enterprise IT Applications and Network Infrastructure.
  • CSV GAMP 5 CPFR Part 11 Validation Worked in V model SOP & SDLC Lifecycle
  • To provide a planned approach for the implementation of the CSV deliverables migration due diligence GXP and Non GXP areas
  • Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
  • Prepare and execute SCA URS MVP VP RTM TP IQ OQ PQ VSR Traceability Matrix FRA / FEMA
  • Exposure to Regulatory Audits
  • The service will benefit if knowledgeable about and capable of advising on product & ingredient regulation within the industry (not mandatory).
  • Using previous use cases and best practice counsel on highly regulated environments
  • Ensure the CSV artefacts are in line and meets regulatory requirements
  • Preferred Experience in Agile Development
  • Knowledge on working in Jira / Service Now

    • Certifications Required

    Certified LIMS Administrator Labware LIMS Certification Labvantage LIMS Certification

    About Company

    Cognizant is a global leader in technology and consulting services, helping businesses transform their operations through digital solutions. Specializing in IT services, including software development, business process outsourcing, and consulting, Cognizant supports clients across industries such as healthcare, financial services, manufacturing, and retail. With a focus on innovation, Cognizant assists organizations in modernizing their technology, improving operational efficiency, and enhancing customer experiences. Headquartered in the U.S., it is consistently ranked among the most admired companies in the world and is a member of the NASDAQ-100.

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