CSV Engineer - Data Integrity Project

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This project has been archived and is not accepting more applications.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

Keywords

Writing

Description

Our pharmaceutical client require an experienced CSV Engineer for a Data Integrity Project at their production facility in Budapest, Hungary. They have around 50 computerised systems onsite, mostly process control and some lab systems. They have seen the need to improve data integrity for these systems, in light of recent FDA and EU regulations.

Duties/Deliverables:
  • Conduct an overall assessment of site systems for data integrity issues.
  • Create and define an action remediation plan for site systems and equipment.
  • Working together with local resources, oversee the remediation process.
  • Establish, coordinate and set up data integrity procedures, processes and policies that efficiently enhance data integrity.
Skillset:
  • Successful candidate should have prior experience of implementing data integrity strategy in a pharmaceutical or biopharmaceutical setting (sound knowledge of CGMP).
  • Strong previous experience implementing CSV strategies, with solid understanding of 21 CFR 11 and EU Annex 11.
  • The ability to communicate effectively, possess good organisational skills, utilise technical procedural writing skill, and be able to work collaboratively in a team environment.
  • Self-starter with the ability to work independently.
  • Fluent English; speaking, reading and writing (Hungarian NOT required).
N.B. This is an excellent opportunity for an experienced CSV Engineer who has recently worked on a Data Integrity improvement project and is open to a short-term assignment in an interesting location.
Start date
2017-05-01
Duration
6 months
From
Quanta Consultancy Services
Published at
22.03.2017
Project ID:
1310954
Contract type
Freelance
To apply to this project you must log in.
Register