Job Description

JOB DESCRIPTION

We are currently seeking a CSV Specialist / CSV Consultant - MES Validation to join our team in Hyderabad, Telangana (IN-TG), India (IN).

Role: CSV Specialist / CSV Consultant - MES Validation

Location: Hyderabad (5 days a week)

30 Days’ Notice period

Required Experience and Skills

  • 5+ years of experience in Computer System Validation (CSV).
  • 3 to 5 years of experience in pharmaceutical, biotech, life sciences, or regulated manufacturing environments.
  • 3+ years of hands-on experience with MES validation and GxP validation lifecycle.
  • Good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+, and data integrity expectations.
  • Experience in validation document preparation, review, execution, and approval workflows.
  • Ability to coordinate with QA, Manufacturing, IT, Automation, and vendor teams.
  • Strong documentation discipline and attention to detail.

    • Preferred...

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