Regulatory Analyst

Job type:
on-site
Start date:
ASAP
Duration:
9-12 months
From:
Salt
Location:
Dublin
Published at:
07/08/2020
Country:
flag_no Ireland
Project ID:
1944329

Warning
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

This position is for a Regulatory Analyst based in Dublin,

Job description:

As a Senior Consultant, you should have 10+ years of hands on experience on providing pharma-regulatory compliance consulting to development projects with the following objectives,

  • Deliver ISRM services to the client they are part of to help ensure that information and IT systems are adequately protected against unauthorized disclosure (confidentiality), unauthorized alteration (integrity), unavailability (availability) and non-compliance
  • To ensure identified project methodology is followed and deliverables are produced in line with validation approach
  • Driving achievements of the Validation/Quality goals by ensuring that the process and standards defined for the project are followed

Mandatory skills:

  • GxP, 21 CFR Part 11, SDLC, GAMP knowledge and SOX knowledge
  • Understand and adhere to the SOPs on Project Management, Change Management, Document Management and Computerized System Validation (CSV) concept
  • Preparation for a compliance audit, attending meetings and assisting in addressing any issues. Also Supporting Project Manager in risk management activities
  • Able to manage direct relations with stakeholders and project team members.
  • Salt is acting as an Employment Business in relation to this vacancy.