Validation Analyst (GCPA)

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.