System Technology Auditing and Compliance Specialist

Job Location(s) IN-Bangalore
Job Number
Job Category
Client Services
Position Type

Job Overview

Essential Job Duties:
 Follow applicable departmental Standard Operating Procedures and Work Instructions.
 Complete required trainings according to required timelines.
 Audits System Life Cycle (SLC) activities and documentation
 Plan, conduct, and lead global internal facility, system, and process audits
 Plan, conduct, and lead external audits of vendors and suppliers
 Participates in client and regulatory visits as the subject matter expert in the field of computerized systems and technology compliance
 Author and review controlled documents including but not limited to SOPs and policies
 Advises internal business, IT, and QA partners on systems and technology compliance
 Leads and actively contributes to process and continuous improvement projects
 Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.
 Other duties as assigned by management.


III. Education/Qualifications/Certifications and Licenses
 A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
 Experience may be substituted for education.


II. Experience:
Minimum Required:
 3 years in regulatory environment (system compliance experience)
 Must have a sound understanding of standard computer system development life cycles to provide necessary guidance to both information technology and operational personnel.
 Thorough knowledge and understanding of GxP and computerized systems regulations and regulatory guidelines.
 Experience applying regulations in at least one GxP discipline and computerized systems standards to the conduct of drug development.
 Ability to confidently interact with clients and regulatory personnel
 Ability to conduct effective training
 Ability to effectively negotiate ideas and suggestions.
 Strong analytical, organizational, and interpersonal skills


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