Added
5 days ago
Type
Full time
Salary
Salary not provided

Related skills

documentation quality assurance data review medical devices gmp

📋 Description

  • Review laboratory data packages for accuracy, completeness, and compliance with approved procedures.
  • Verify calculations, transcriptions, and data entries for correctness.
  • Primary focus on sterility by membrane filtration studies.
  • Review test documentation to ensure all required information is present and properly documented.
  • Identify discrepancies, documentation errors, and potential compliance concerns and escalate as
  • Confirm that investigations, deviations, and corrections are adequately documented.

🎯 Requirements

  • M.Sc in Microbiology with 1-2 years of experience
  • Familiarity with regulated environments (GMP, GxP, clinical research, or equivalent)
  • Strong written communication skills with attention to detail and consistency
  • Demonstrated ability to manage multiple deliverables and competing priorities
  • Honest, dependable, demonstrated ability to self-manage
  • Detail oriented, accurate, precise
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