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Lab Validation Analyst

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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

    ISTQB Certified Tester Certified Software Quality Analyst (CSQA)

    About us

    Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World’s Best Employers 2024) is consistently listed among the most admired companies in the world.

    Learn how Cognizant helps clients lead with digital at www.cognizant.com.

    What we offer

    • The chance to work with impact. Here, you’re empowered to bring your biggest thinking to help our company and clients improve everyday life.
    • Ownership over your career. Stay at the top of your game through our award-winning learning and development ecosystem. And when your ambitions change or we offer new opportunities, we help you pivot by providing reskilling, on-the-job learning and guidance to find new roles that might be a better fit.
    • The opportunity to thrive on a high-caliber team with heart. We celebrate each other’s experiences and perspectives and promote a sense of belonging through our affinity groups and diversity and inclusion initiatives.
    • A comprehensive total rewards package, including a competitive salary and pension plan with matching contributions.
    • Flexible health and financial benefits to support you and your eligible dependents—from day one.
    • True work-life balance. Be at your best through paid time off, flexible work arrangements, volunteering opportunities, social events, and so much more.  

    Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.

    If you have a disability that requires reasonable accommodation to search for a job opening or apply, please email [email protected] with your request and contact information.

    Disclaimer:
    Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.

    Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government-issued ID during each interview.

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