Covance Job - 32848759 | CareerArc
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Company: Covance
Location: Bengaluru, KA, India
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job Overview:

Job Location: Bangalore, India

 

  • 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, or 5.5 years in a validation or regulatory position dealing with SOPS and computer systems requirement specification. 
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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