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Global CVQA Specialist 's-Hertogenbosch Netherlands,  

Charles River (company)


Posted on : 16 April 2017

Project Description


Description:
  • The organisation employs ~ 10,000 staff worldwide. 
  • Our company here in the Netherlands is a well-known, internationally operating contract research organization. 
  • The company specializes in areas such as environmental and safety research for new and existing drugs, chemical substances and products. 
  • Quality-thinking is the essence of our company.
  •  Our clients are international pharmaceutical, chemical and agro-chemical companies.
  • We would like to get in touch with an enthusiastic GLOBAL COMPUTER VALIDATION QA SPECIALIST



Your tasks:
  • Provide quality assurance monitoring and audits of all company  computer validation projects globally to assure compliance with applicable regulations, corporate policies, and procedures.
  • Assist in periodic assessments of globally controlled IT regulated activities;
  • Assist in the development and maintenance of the computer validation training programs and present training in regulatory requirements for validation, maintenance, and operation of computer technologies;
  • Provide compliance support to Computer Validation QA managers on multisite and global computer systems, assisting with the development and/or review of validation deliverables.
  • Provide compliance guidance to operational personnel on regulatory requirements for computerized system validation, development of user requirements specifications, testing strategies, and documentation requirements.


Your profile:
  • Bachelor's degree or equivalent in a scientific discipline and/or computer related field.
  • 2-4 years related experience in a pharmaceutical, biotechnology and/or biomedical industry. 
  • Working knowledge of computer validation requirements in government regulations;
  • Excellent communication and interpersonal skills
  • A team player with a pro-active, client-oriented, and critical attitude;
  • Proficiency in computer-based word processing, spreadsheet and presentation applications require;



Our offer:
  • A challenging job in an international working team;
  • The possibility to further develop in your area of expertise;
  • Good primary and secondary terms of employment;
  • An open culture in a pleasant and informal atmosphere;
  • A position for 40 hours per week.

Locations

's Hertogenbosch Netherlands

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