Validation Administrator II (GCPA) (RAVE)
Laboratory Corporation of America Holdings (Covance)
Bangalore, India
2d ago
  • Supports validation activities as assigned and serves as a validation team member.
  • Review to make oneself familiar with the EDC specifications.
  • Writes and assembles validation documentation packages such as but not limited to, validation plan, testing results, traceability matrix, validation reports.
  • Support virtual global validation team as needed to complete validation projects
  • Maintains and utilizes knowledge of SOPs and validation procedures / standards in relation to system development cycle.
  • Executes test cases against requirement, enters errors in error tracking logs and performs re-test documenting resolutions.
  • Supports in maintaining testing documentation and files.
  • Carry out all activities according to Covance SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP).
  • Perform other duties as assigned by senior staff and / or manager.
  • University / college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.
  • g., nursing certification, computer science, medical or laboratory technology)

  • Basic knowledge of drug development process and Clinical Data Management System.
  • Basic knowledge of relational databases preferred
  • Fluent in English, both written and verbal
  • Two to Four (2-4) relevant work experience to include data management and database support :
  • Good problem solving skills and a proactive approach
  • Good oral and written communication skills
  • Basic knowledge of clinical trial process to support operations preferred
  • Ability to work in a team environment
  • Ability to work effectively under supervision
  • Ability to prioritize work
  • Self-motivated
  • Good time management skills and maintain the highest standards of quality work
  • A cooperative and team oriented approach
  • 2021-07-06 13 : 53 : 03

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