QA Auditor IV (Preclinical)

Job Location(s) IN-Bangalore
Job Number
Job Category
Quality Assurance
Position Type

Job Overview

 Evaluates responses to inspection reports and performs follow-up with respondents,
management, or others, if needed, to ensure resolution
 Report on relevant quality metrics (for multiple topics/departments) and highlight trends
 Provide consultation to the operational team (e.g. as they revise/write controlled documents)
 Delivery of training in performance of audits (basic, intermediate audit activities)
 Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills]
 Contribute to local Quality initiatives and process improvement initiatives aimed at improving
compliance and/or efficiency of the local QA organization
 Create and/or re-write QA SOPs based on findings from local quality initiatives.
 Organizing, Prioritizing and Managing all aspects of workload to meet business needs.
 Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated
in applicable controlled documents, are followed
 Perform other duties as assigned by management.


 A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science
 Experience may be substituted for education


 4 years in regulatory environment (experience in GXP roles) and willingness to 
Knowledge of industry quality systems/standards and able to apply (applicable) regulations in
order to monitor compliance
 Experienced GxP auditor
 Experienced in process improvement
 Clear communication skills, including ability to provide clear feedback
 Able to clearly articulate processes in order to provide training
 Able to influence process improvement initiatives / offer solutions


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