Interim CSV Engineer - Drenthe

Function Group: Engineering / CSV Engineer

Introduction

QTC Recruitment is a reliable recruitment partner, specialising in search and selection of professionals in the life sciences industry. We provide tailored services all over Europe, offering a search proposal to find specialised candidates for demanding positions in a competitive labour market. Through decades of experience in life sciences recruitment, we have developed an extensive network of leading employers and specialists in Europe. Our goal is to make both clients and candidates happy with a new job opportunity or a matching specialist through our reliable, transparent, and personal way of doing business. QTC is all about making a difference for you on Quality, Time, and Cost.

Organization

Our client is a dynamic and innovative engineering company working in the pharmaceutical sector. It is a major player within the international market, which is active in Europe. At the moment I am looking for a Interim CSV Engineer for a project of 12 months. The CSV Engineer is responsible for managing IT validations from start to finish (also often referred to as computerised system validation). This concerns the validation of IT systems that are typical for pharmaceutical production companies

Function

  • Performing GMP impact assessments
  • Ensure that the quality requirements from the regulations and standards are translated correctly to the user requirements of a system. Consider requirements regarding Back-up & Restore, Incident Management
  • Disaster Recovery, Electronic Records and Electronic Signatures
  • Determine and implement a validation approach for the system (including any interfaces)
  • Facilitating so-called Design Verification (or Design Qualification) sessions
  • Managing the tests according to a structured and formally established procedure

Requirements

  • Bachelor +
  • Knowledge of the formulation and packaging processes
  • Preferably knowledge of Electronic Batch Records Systems, Laboratory Information Systems or systems that are comparable in terms of complexity and degree of integration
  • Knowledge of GMP regulations (Eudralex Volume 4, 21 CFR Parts 210, 211 and 11) and ISPE Good Practice Guides (GAMP5)
  • Knowledge of ICT and Industrial Automation
  • Knowledge of System Life Cycle methodologies

Application

Aron Berhane
Senior Associate | Medical Devices

+31(0)23-7548660
+31(0)6-30306982
a.berhane@qtcrecruitment.com

Apply

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