Validation Analyst (GCPA)
Labcorp Drug Development
Bangalore, India
5d ago

Job Overview :

  • Leads validation projects as assigned and serve as a validation team member on multiple assignments as designated by the management with support from other team members as needed.
  • Review EDC specifications from Lead Data Manager.
  • Writes and assembles critical validation documentation packages including the Validation Plan, Testing Results, Traceability Matrix, and Validation Report.
  • Provide coordination of virtual global validation teams as needed to complete validation projects.
  • Maintains and utilizes a strong knowledge of SOPS and validation work procedures / standards in relation to the System Development Life Cycle.
  • Executes test cases against these requirements, enter errors in to error tracking logs and performs retests documenting resolutions, and maintain validation testing documentation and files.
  • Education / Qualifications :

    BS / BA degree preferably in the sciences or related field

    Experience :

  • Minimum 5.5 to 8 years of pharmaceutical or equivalent experience.
  • Strong attention to detail.
  • Strong analytical skills, preferably in a GCP environment.
  • Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO or related industry.
  • Problem Solving / Logic Skills.
  • Strong communication and interpersonal skills.
  • Strong MS / Office skills in particular with Excel and Word.
  • Understanding of Electronic Data Capture (EDC) and the clinical trial process preferred.
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