Global CVQA Specialist - Netherlands
Want to know company name or location? Company managed [?]
- 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
- 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.
- 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;
- 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.