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Data Validation Expert

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Chandigarh, Chandigarh, India beBeeCSVspecialist Full time ₹ 12,00,000 - ₹ 15,00,000
Job Summary

We are seeking a highly skilled CSV Specialist to join our team.

Key Responsibilities:
  • Develop and execute comprehensive CSV protocols and plans for various computer systems, including laboratory systems (Chromeleon, LIMS, Empower), engineering systems (PLC, SCADA, HMI, MES), manufacturing systems, clinical trial management systems (CTMS), and SAP systems.
  • Conduct risk assessments and identify potential compliance gaps related to computer systems.
  • Perform thorough system assessments, including data integrity reviews, to ensure compliance with ALCOA+ principles.
  • Author and review validation documentation, including protocols, reports, and deviations.
  • Collaborate effectively with cross-functional teams to ensure successful project delivery.
  • Stay abreast of evolving regulatory requirements and industry best practices in CSV.
Requirements:
  • Strong understanding of CSV principles and methodologies, with a focus on regulated industries (Pharmaceutical, Biotech, Medical Devices).
  • In-depth knowledge of relevant regulations, including 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Proven experience in validating various computer systems, including those listed above.
  • Expertise in data integrity principles (ALCOA+) and their application in CSV.
  • Excellent written and verbal communication, interpersonal, and presentation skills.
  • Strong analytical and problem-solving abilities.
  • Ability to work independently and as part of a team.
Preferred Skills:
  • Experience with specific software applications (Chromeleon, LIMS, Empower, PLC, SCADA, HMI, MES, SAP).
  • Knowledge of Excel sheet validation techniques.
  • Experience in infrastructure qualification.
Keyword: CSV Specialist