regulatory analyst -ba ii - empower in bengaluru / bangalore

posted
contact
randstad india
position type
permanent
apply now

posted
location
bengaluru / bangalore
function
Pharma, healthcare & lifesciences
position type
permanent
experience
6
reference number
64925
contact
randstad india

job description

regulatory analyst -ba ii - empower in bengaluru / bangalore

The position

 

This position is responsible for providing Functional support for Empower, Chromeleon and other CDS systems out of Product Supply in our Manufacturing IT department. The position holder would Co-Ordinate day to day execution of Incident and Change Management and drive/ participate in work related to implementation of System enhancements or feature releases. You are expected to prepare and update user manuals. Further you would be responsible for Test Co-ordination/ Validation align with QA and help in audits. You would be aligning with vendors, users and Line of Business to ensure the quality and GxP compliance of the System and changes implemented in the System

Qualification

  • Masters degree or Bachelors degree or similar graduate degree in relevant fields
  • 5-6 years of experience with similar role
  • 4+ years of relevant technology experience and with regulatory requirements (21 CFR Part 11, GMP)
  • 2+ years of pharmaceutical industry experience
  • Good interpersonal skills
  • Excellent communication skills – written and oral in English
  • Large degree of flexibility and the ability to work under strong time pressure
  • ITIL Certification is good to have

 

skills

GMP, 21 CFR Part 11

qualification

B.E/B.Tech, BCA, BBA