BrightOwl Loader Loading

Application Support Engineer Chennai India,  

Navitas Life Sciences (company)


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

Locations

Chennai India

Find a Job Find Candidates

Similar Jobs

More jobs from Navitas Life Sciences

Other jobs in India

Other jobs in Chennai

Other jobs from Navitas Life Sciences in Chennai

Other similar job in Chennai

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like