BrightOwl Loader Loading

Application Support Engineer - India  

Company managed [?] Still accepting applications

Posted on : 22 December 2017

Project Description

Category: Executive
Location: Chennai
Job Type:
Full Time
Education: Graduate Degree

Job Description:

  • Troubleshoot issues and problems in the two applications.
  • Triage with client and product vendors to solve issues.
  • Analyze, recommend, and implement process improvements.
  • Provide domain support to client who are into regulatory submissions and product registrations and who operations globally.
  • Collaborate with server and database vendors, business units, IT, external service providers, consultants, operations and technical support.
  • Manage & Upgrade systems to newer versions.
  • Maintain and update validation system documentation for change management.
  • Develop test scripts, IQ/OQ/PQ scripts, and have the team execute scripts and document results.
  • Support systems architecture development and document support.
  • Support business requirements analysis.
  • Provide training to business users.
  • Perform related duties as assigned or requested.
  • Receive general direction from the Application Manager/Account Manager to position and support applications in the market.


Preferred Skills:

  • 5+ years of proven Application Management Support preferably in the pharmaceutical industry or related industries, and 4-5 years of experience in drug regulatory publishing, product registration and Document, Quality management systems.
  • Strong knowledge of Aris Register and Extedo’s eCTD Manager softwares.
  • System support and maintenance experience in a regulated environment is a must.
  • Strong knowledge of document and submission management business processes and regulations for regulatory submissions particular to the FDA, EMA and other Health Authority new drug applications.
  • Excellent communication and writing skills
  • Expert knowledge in ICH rules and recommendations (HL7 knowledge is a plus.)
  • Area of software knowledge:
    • Extedo eCTD Manager, Aris Register, ISI Publisher, and other emerging electronic dossier solutions.
    • SME in Regulatory space with excellent domain knowledge in Regulatory submissions and product registrations.
    • Knowledge in Article 57, XEVMPD, IDMP and other important guidelines.

If you would like to apply for this position, or would like a discussion about this, or any other role, please send your contact details, together with your curriculum vitae to:
recruitment.india@navitaslifesciences.com